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Celecoxib 100 mg Capsule, 100-count — NDC 50228-0157-01 package photo

Celecoxib 100 mg Capsule, 100-count

by ScieGen Pharmaceuticals, Inc. · 100 CAPSULE in 1 BOTTLE (50228-157-01)
NDC 50228-0157-01
🏷️ FDA NDC (as labeled) 50228-157-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0621 NADAC Per package$6.21 / 100 capsules Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.2084/unit · Part D plans $0.2958/unit — full pricing hub ↓
Also comes in: 30 capsules 50228-0157-30 500 capsules 50228-0157-05 1000 capsules 50228-0157-10
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Celecoxib (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 13, 2025 — Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules (AvKARE) · FDA recall D-0460-2025
Class II · May 9, 2025 — Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule (Alembic Pharmaceuticals Limited) · FDA recall D-0459-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 50228-157-01
Product NDC 50228-157
11-digit billing NDC 50228015701
NCPDP billing unit EA — each (per item)
RxCUI 205322, 205323, 349514, 686379
UNII JCX84Q7J1L
UPC 0350228158107, 0350228159609, 0350228157018, 0350228157100 +10 more
Application # ANDA205129
SPL Set ID 8709cbe7-3de1-4908-a0a9-53002bcee15b
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-12-03
Route ORAL
Dosage form CAPSULE
Substance CELECOXIB
GPI-14 66100525000120
GPI class Celecoxib
GCN Seq No 041285
GCN 42001
HICL code 018979
Ingredient (HICL) Celecoxib
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2L
Therapeutic class — specific (HIC3) Nsaids,Cyclooxygenase-2(Cox-2) Selective Inhibitor
AHFS code 28:08.04.08
AHFS class Cyclooxygenase-2 (Cox-2) Inhibitors
FDB label name CELECOXIB 100 MG CAPSULE
FDB brand name Celecoxib
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 50228-157-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50228-0157-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other antineoplastic agents, Coxibs, Dihydropyridine derivatives
How it works Cyclooxygenase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerScieGen Pharmaceuticals, Inc.
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA205129 (ANDA)
Labeler code50228
First marketedDec 2020
Product typeHuman Prescription Drug
Portfolio102 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CELECOXIB 100 MG CAPSULE Ingredient Celecoxib
📖 What it is MedlinePlus · NLM

Celecoxib is used to relieve pain, tenderness, swelling and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), and ankylosing spondylitis (arthritis that mainly affects the spine). Celecoxib is also used to treat juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older. Celecoxib is also used to treat painful menstrual periods and to relieve other types of short-term pain including pain caused by injuries, surgery...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Celecoxib is used for several different conditions depending on the form you have. The capsules treat arthritis pain (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis),...
  • What conditions is celecoxib actually used for?
  • It depends on which form you have. Regular celecoxib capsules at lower doses can be taken with or without food. At higher doses, taking them with food actually helps your body abso...
  • Should I take celecoxib with food or on an empty stomach?
📖 Read our full Celecoxib guide →
1
Nutrient depletion considerations

Celecoxib may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Celecoxib nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeCapsule
ImprintSG;158
Size18 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.062 $6.21 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.2084 $20.84 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.2958 $29.58 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.118 $0.062
▼ Down 38% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Celecoxib 100 mg 00591-3983-01 Actavis 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 00904-7550-61 Major 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 11788-0113-01 AiPing 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 16714-0732-01 NorthStar 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 23155-0964-01 Avet 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 27808-0296-01 Cranbury 100 capsules $0.062 AB Availability likely —
celecoxib 100 mg 33342-0156-11 Macleods 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 42571-0143-01 Micro 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 42806-0721-01 EPIC 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mgthis 50228-0157-01 ScieGen 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 50268-0168-15 AvPAK 50 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 60505-3848-01 Apotex 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 60687-0436-01 American 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 62135-0021-60 Chartwell 60 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 65862-0908-01 Aurobindo 100 capsules $0.062 AB Availability likely —
celecoxib 100 mg 68180-0396-01 Lupin 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 69367-0301-01 Westminster 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 75834-0237-01 NIVAGEN 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 82009-0068-05 Quallent 500 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 83301-0011-01 Mullan 100 capsules $0.062 AB Availability likely —
celecoxib 100 mg 13668-0441-01 Torrent 100 capsules $0.090 AB FDA listed +44%
Celebrex 100 mg 58151-0083-01 Viatris 100 capsules $9.542 AB Availability likely +15268%
Celecoxib 100 mg 00615-8572-39 NCS 30 capsules — AB FDA listed —
Celecoxib 100 mg 29300-0158-01 Unichem 100 capsules — — FDA listed —
Celecoxib 100 mg 46708-0268-10 Alembic 100 capsules — AB FDA listed —
Celecoxib 100 mg 50090-6380-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 51655-0059-52 Northwind 30 capsules — AB FDA listed —
Celecoxib 100 mg 51655-0436-25 Northwind 60 capsules — AB FDA listed —
celecoxib 100 mg 55700-0613-30 Quality 30 capsules — AB FDA listed —
Celecoxib 100 mg 57582-0212-01 Tianjin 100 capsules — AB FDA listed —
Celecoxib 100 mg 60290-0017-01 Umedica 100 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0649-60 ST. 60 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0995-15 St. 15 capsules — AB FDA listed —
Celecoxib 100 mg 62332-0141-08 Alembic 80 capsules — AB FDA listed —
Celecoxib 100 mg 63187-0301-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 100 mg 63187-0643-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 100 mg 68788-4095-03 Preferred 30 capsules — AB FDA listed —
celecoxib 100 mg 68788-7286-03 Preferred 30 capsules — AB FDA listed —
Celecoxib 100 mg 68788-8206-03 Preferred 30 capsules — AB FDA listed —
Celecoxib 100 mg 69097-0422-02 Cipla 30 capsules — AB FDA listed —
Celecoxib 100 mg 69117-0021-01 Yiling 60 capsules — AB FDA listed —
Celecoxib 100 mg 70247-0007-10 Qingdao 100 capsules — AB FDA listed —
Celecoxib 100 mg 70518-3424-00 REMEDYREPACK 30 capsules — AB Discontinued —
Celecoxib 100 mg 70518-3826-00 REMEDYREPACK 90 capsules — AB FDA listed —
Celecoxib 100 mg 70518-4009-00 REMEDYREPACK 100 capsules — AB FDA listed —
Celecoxib 100 mg 70518-4508-00 REMEDYREPACK 60 capsules — AB FDA listed —
Celecoxib 100 mg 71205-0020-30 Proficient 30 capsules — AB FDA listed —
celecoxib 100 mg 71205-0439-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 100 mg 71209-0055-03 Cadila 60 capsules — AB FDA listed —
Celecoxib 100 mg 71335-0292-01 Bryant 30 capsules — AB FDA listed —
celecoxib 100 mg 71335-0936-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-1804-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-2019-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-2222-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 72162-2254-05 Bryant 500 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0123-30 Direct 30 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0662-60 Direct_Rx 60 capsules — AB FDA listed —
Celecoxib 100 mg 72241-0023-03 Modavar 60 capsules — AB FDA listed —
celecoxib 100 mg 76420-0243-01 Asclemed 1 capsule — AB FDA listed —
Celecoxib 100 mg 76420-0727-01 Asclemed 1 capsule — AB FDA listed —
Celecoxib 100 mg 76420-0843-00 Asclemed 1000 capsules — AB FDA listed —
Celecoxib 100 mg 77771-0157-01 Radha 100 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0142-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0167-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0321-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0323-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 82804-0151-60 Proficient 60 capsules — AB FDA listed —
Celecoxib 100 mg 85509-1237-01 PHOENIX 120 capsules — AB FDA listed —
celecoxib 100 mg 85534-0014-00 HAWAII 30 capsules — AB FDA listed —
Celecoxib 100 mg 85534-0067-00 HAWAII 30 capsules — AB FDA listed —
Celecoxib 100 mg 55154-0160-00 Cardinal 10 capsules — AB FDA listed —
Celecoxib 100 mg 50090-8031-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0685-72 Direct_Rx 120 capsules — AB FDA listed —
Celecoxib 100 mg 50090-8036-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0942-60 St. 60 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 50228-0157-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
37.7K
Units reimbursed last 4 qtrs
2.1M
Gross reimbursed last 4 qtrs
$438.9K
Avg / prescription
$11.65
Avg / unit
$0.2084
Latest quarter Q4 2025
7.9KRx
Medicaid pays / ea
$0.2084
gross reimbursed
vs
NADAC / ea
$0.0621
acquisition cost
=
Spread
+$0.1463
+236% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
39% FFS 61% MCO
Fee-for-service · 14,834 Rx Managed care · 22,827 Rx
State Medicaid map
Alaska: 5,344 units · 729 per 100k residents AK Maine: 18,361 units · 1,316 per 100k residents ME Washington: 7,580 units · 97.0 per 100k residents WA Idaho: 6,755 units · 344 per 100k residents ID Montana: 11,222 units · 991 per 100k residents MT North Dakota: 3,870 units · 494 per 100k residents ND Minnesota: 24,581 units · 428 per 100k residents MN Wisconsin: 53,202 units · 900 per 100k residents WI Michigan: 83,831 units · 835 per 100k residents MI New York: 314,357 units · 1,606 per 100k residents NY Vermont: 4,760 units · 736 per 100k residents VT New Hampshire: 10,878 units · 776 per 100k residents NH Oregon: 21,766 units · 514 per 100k residents OR Nevada: 993 units · 31.1 per 100k residents NV Wyoming: no data reported WY South Dakota: 16,264 units · 1,770 per 100k residents SD Iowa: 18,904 units · 589 per 100k residents IA Illinois: 101,168 units · 806 per 100k residents IL Indiana: 2,651 units · 38.6 per 100k residents IN Ohio: 209,986 units · 1,782 per 100k residents OH Pennsylvania: 446,325 units · 3,444 per 100k residents PA New Jersey: 122,870 units · 1,323 per 100k residents NJ Massachusetts: 18,093 units · 258 per 100k residents MA California: 188,198 units · 483 per 100k residents CA Utah: 3,384 units · 99.0 per 100k residents UT Colorado: 29,671 units · 505 per 100k residents CO Nebraska: 15,935 units · 806 per 100k residents NE Missouri: 70,677 units · 1,141 per 100k residents MO Kentucky: 23,856 units · 527 per 100k residents KY West Virginia: 32,978 units · 1,863 per 100k residents WV Virginia: 31,068 units · 356 per 100k residents VA Maryland: 64,521 units · 1,044 per 100k residents MD Connecticut: 14,962 units · 414 per 100k residents CT Rhode Island: no data reported RI Arizona: 4,579 units · 61.6 per 100k residents AZ New Mexico: 1,078 units · 51.0 per 100k residents NM Kansas: 14,124 units · 480 per 100k residents KS Arkansas: 8,502 units · 277 per 100k residents AR Tennessee: 9,218 units · 129 per 100k residents TN North Carolina: 22,761 units · 210 per 100k residents NC South Carolina: 1,886 units · 35.1 per 100k residents SC Delaware: 11,076 units · 1,074 per 100k residents DE Oklahoma: 22,690 units · 560 per 100k residents OK Louisiana: 1,964 units · 42.9 per 100k residents LA Mississippi: no data reported MS Alabama: 6,294 units · 123 per 100k residents AL Georgia: no data reported GA D.C.: 5,618 units · 827 per 100k residents DC Hawaii: no data reported HI Texas: 7,125 units · 23.4 per 100k residents TX Florida: 10,041 units · 44.4 per 100k residents FL
Units reimbursed · per 100k residents
23.43,444
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Pennsylvania 3,444 /100k
2 West Virginia 1,863 /100k
3 Ohio 1,782 /100k
4 South Dakota 1,770 /100k
5 New York 1,606 /100k
6 New Jersey 1,323 /100k
7 Maine 1,316 /100k
8 Missouri 1,141 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 capsules this page50228-0157-01 37,661 Rx · $438,912
500 capsules50228-0157-05 5,055 Rx · $98,974
1000 capsules50228-0157-10 No Medicaid data
30 capsules50228-0157-30 No Medicaid data
Drug total (last 4 qtrs): 42,716 Rx · 2,363,144 units · $537,886 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Celecoxib — the program that covers self-administered drugs. 25 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Celecoxib. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$38.36M
Claims incl. refills
1.6M
Beneficiaries
1.1M
Spend / beneficiary
$34.12
Spend / claim
$23.40
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Celecoxib — the ingredient across all brands.

Top reported reactions

Pain12,605
Arthralgia11,261
Fatigue10,100
Nausea9,771
Drug Hypersensitivity7,939
Diarrhoea7,598
Headache7,510

Age at onset

Neonate63
Infant15
Child143
Adolescent146
Adult9,514
Elderly5,530

Reporter sex

130,888 reports
Male · 29%
Female · 70%
Unknown · 0%

Serious outcomes

Hospitalization40,400
Life-threatening7,448
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 8,494 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
50228-0157-01 You're viewing this 100 CAPSULE in 1 BOTTLE (50228-157-01) $0.0621 / ea $6.21 2020-12-03 Active
50228-0157-05 500 CAPSULE in 1 BOTTLE (50228-157-05) $0.0621 / ea $31.05 2020-12-03 Active
50228-0157-10 1000 CAPSULE in 1 BOTTLE (50228-157-10) — — 2020-12-03 Active
50228-0157-30 30 CAPSULE in 1 BOTTLE (50228-157-30) — — 2020-12-03 Active

You're viewing one of 4 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0621 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 88% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 50228-0157-01?
NDC 50228-0157-01 is a 100-count package — 100 capsule in 1 bottle.
What is the difference between NDC 50228-0157-01 and NDC 50228-0157-30?
Both are Celecoxib 100 mg Capsule — the drug itself is identical. NDC 50228-0157-01 is the 100-count package, while NDC 50228-0157-30 is the 30 capsules package.
What NDC number is used to bill for this package of Celecoxib 100 mg Capsule?
Bill NDC 50228-0157-01 — the 11-digit billing format is 50228015701. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. [ see Warnings and Precautions (5.1) ] Celecoxib capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. [ see Contraindications (4) and Warnings and Precautions (5.1) ] Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. [ see Warnings and Precautions (5.2) ] WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

This risk may occur early in the treatment and may increase with duration of use. ( 5.1 ) Celecoxib capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.1 ) NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. ( 5.2 )

🎯 Indications and Usage 175 words ▾

1. INDICATIONS AND USAGE Celecoxib capsules are indicated Celecoxib capsules are nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Acute Pain (AP) ( 1.5 ) Primary Dysmenorrhea (PD) ( 1.6 )

1.1Osteoarthritis(OA) For the management of the signs and symptoms of OA [ see Clinical Studies (14.1) ]

1.2Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [ see Clinical Studies (14.2) ]

1.3Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies (14.3) ]

1.4Ankylosing Spondylitis (AS) For the management of the signs and symptoms of AS [ see Clinical Studies (14.4) ]

1.5Acute Pain For the management of acute pain in adults [ see Clinical Studies (14.5) ]

1.6Primary Dysmenorrhea For the management of primary dysmenorrhea [ see Clinical Studies (14.5) ]

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1 ) OA: 200 mg once daily or 100 mg twice daily ( 2.2 , 14.1 ) RA: 100 mg to 200 mg twice daily ( 2.3 , 14.2 ) JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg ( 2.4 , 14.3 ) AS: 200 mg once daily single dose or 100 mg twice daily.

If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit ( 2.5 , 14.4 ) AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed ( 2.6 , 14.5 ) Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). ( 2.7, 8.6 , 12.3 ) Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers.

(2.7 , 8.8 , 12.3 ).

2.1General Dosing Instructions Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. These doses can be given without regard to timing of meals.

2.2Osteoarthritis For OA, the dosage is 200 mg per day administered as a single dose or as 100 mg twice daily.

2.3Rheumatoid Arthritis For RA, the dosage is 100 mg to 200 mg twice daily.

2.4Juvenile Rheumatoid Arthritis For JRA, the dosage for pediatric patients (age 2 years and older) is based on weight. For patients > 10 kg to < 25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.

For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2°C to 8°C/ 35°F to 45°F).

2.5Ankylosing Spondylitis For AS, the dosage of celecoxib capsules is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.

2.6Management of Acute Pain and Treatment of Primary Dysmenorrhea For management of Acute Pain and Treatment of Primary Dysmenorrhea, the dosage is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.

2.7Special Populations Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%. The use of celecoxib capsules in patients with severe hepatic impairment is not recommended [ see Warnings and Precautions (5.3) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ]. Poor Metabolizers of CYP2C9 Substrates In adult patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin), initiate treatment with half of the lowest recommended dose.

In patients with JRA who are known or suspected to be poor CYP2C9 metabolizers, consider using alternative treatments [ see Use in Specific populations (8.8), and Clinical Pharmacology (12.5) ].

💊 Dosage Forms and Strengths 141 words ▾

3. DOSAGE FORMS AND STRENGTHS Celecoxib capsules: 50 mg white to off-white powder filled in size "4" hard gelatin white capsules, with reverse printed white on red band with markings SG on cap and 156 on body. 100 mg white to off-white powder filled in size "4" hard gelatin white capsules, with reverse printed white on blue band with markings SG on cap and 157 on body.

200 mg white to off-white powder filled in size "2" hard gelatin white capsules, with reverse printed white on gold band with markings SG on cap and 158 on body. 400 mg white to off-white powder filled in size "0" hard gelatin white capsules, with reverse printed white on green band with markings SG on cap and 159 on body. Celecoxib capsules: 50 mg, 100 mg, 200 mg and 400 mg ( 3 )

⛔ Contraindications 143 words ▾

4. CONTRAINDICATIONS Celecoxib capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [ see Warnings and Precautions (5.7, 5.9) ]. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients [ see Warnings and Precautions (5.7 , 5.8 ) ]. In the setting of CABG surgery [ see Warnings and Precautions (5.1) ]. In patients who have demonstrated allergic-type reactions to sulfonamides [ see Warnings and Precautions (5.7) ].

Known hypersensitivity to celecoxib, or any components of the drug product or sulfonamides ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) In the setting of CABG surgery ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.

Monitor blood pressure ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of celecoxib capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5 ) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of celecoxib capsules in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs ( 5.7 ) Exacerbation of Asthma Related to Aspirin Sensitivity : Celecoxib capsules are contraindicated in patients with aspirin-sensitive asthma.

Monitor patients with preexisting asthma (without aspirin sensitivity) ( 5.8 ) Serious Skin Reactions : Discontinue celecoxib capsules at first appearance of skin rash or other signs of hypersensitivity ( 5.9 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically ( 5.10 ) Fetal Toxicity: Limit use of NSAIDs, including celecoxib capsules, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus ( 5.11 , 8.1 ) Hematologic Toxicity : Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia ( 5.12 , 7 )

5.1Cardiovascular Thrombotic Events Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

In the APC (Adenoma Prevention with Celecoxib) trial, there was about a threefold increased risk of the composite endpoint of cardiovascular death, MI, or stroke for the celecoxib capsules 400 mg twice daily and celecoxib capsules 200 mg twice daily treatment arms compared to placebo. The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction [ see Clinical Studies (14.7) ]. A randomized controlled trial entitled the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs.

Ibuprofen Or Naproxen (PRECISION) was conducted to assess the relative cardiovascular thrombotic risk of a COX-2 inhibitor, celecoxib, compared to the non-selective NSAIDs naproxen and ibuprofen. Celecoxib 100 mg twice daily was non-inferior to naproxen 375 mg to 500 mg twice daily and ibuprofen 600 mg to 800 mg three times daily for the composite endpoint of the Antiplatelet Trialists’ Collaboration (APTC), which consists of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, and non-fatal stroke [ See…

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions (5.2) ] Hepatotoxicity [ see Warnings and Precautions (5.3) ] Hypertension [ see Warnings and Precautions (5.4) ] Heart Failure and Edema [ see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions (5.6) ] Anaphylactic Reactions [ see Warnings and Precautions (5.7) ] Serious Skin Reactions [ see Warnings and Precautions (5.9) ] Hematologic Toxicity [ see Warnings and Precautions (5.12) ] Most common adverse reactions in arthritis trials (>2% and >placebo) are: abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc., at 855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Of the celecoxib capsules-treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain.

More than 8,500 patients received a total daily dose of celecoxib capsules of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily). Approximately 3,900 patients received celecoxib capsules at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more. Pre-marketing Controlled Arthritis Trials Table 1 lists all adverse events, regardless of causality, occurring in ≥ 2% of patients receiving celecoxib from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group.

Since these 12 trials were of different durations, and patients in the trials may not have been exposed for the same duration of time, these percentages do not capture cumulative rates of occurrence. Table 1: Adverse Events Occurring in ≥2% of Celecoxib Capsules Patients from Pre-marketing Controlled Arthritis Trials CBX Placebo NAP DCF IBU N=4,146 N=1,864 N=1,366 N=387 N=345 Gastrointestinal Abdominal Pain 4.1% 2.8% 7.7% 9.0% 9.0% Diarrhea 5.6% 3.8% 5.3% 9.3% 5.8% Dyspepsia 8.8% 6.2% 12.2% 10.9% 12.8% Flatulence 2.2% 1.0% 3.6% 4.1% 3.5% Nausea 3.5% 4.2% 6.0% 3.4% 6.7% Body as a whole Back Pain 2.8% 3.6% 2.2% 2.6% 0.9% Peripheral Edema 2.1% 1.1% 2.1% 1.0% 3.5% Injury-Accidental 2.9% 2.3% 3.0% 2.6% 3.2% Central, Peripheral Nervous system Dizziness 2.0% 1.7% 2.6% 1.3% 2.3% Headache 15.8% 20.2% 14.5% 15.5% 15.4% Psychiatric Insomnia 2.3% 2.3% 2.9% 1.3% 1.4% Respiratory Pharyngitis 2.3% 1.1% 1.7% 1.6% 2.6% Rhinitis 2.0% 1.3% 2.4% 2.3% 0.6% Sinusitis 5.0% 4.3% 4.0% 5.4% 5.8% Upper Respiratory Infection 8.1% 6.7% 9.9% 9.8% 9.9% Skin Rash 2.2% 2.1% 2.1% 1.3% 1.2% CBX = Celecoxib capsules 100 mg to 200 mg twice daily or 200 mg once daily; NAP = Naproxen 500 mg twice daily; DCF = Diclofenac 75 mg twice daily; IBU = Ibuprofen 800 mg three times daily.

In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving celecoxib capsules and 6.1% for patients receiving placebo. Among the most common reasons for discontinuatio…

🔄 Drug Interactions ~3 min read ▾

7. DRUG INTERACTIONS See Table 3 for clinically significant drug interactions with celecoxib. Table 3: Clinically Significant Drug Interactions with Celecoxib Drugs That Interfere with Hemostasis Clinical Impact: Celecoxib and anticoagulants such as warfarin have a synergistic effect on bleeding.

The concomitant use of Celecoxib and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.

Intervention: Monitor patients with concomitant use of celecoxib capsules with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding [ see Warnings and Precautions (5.12) ]. Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [ see Warnings and Precautions (5.2) ].

In two studies in healthy volunteers, and in patients with osteoarthritis and established heart disease respectively, celecoxib (200 mg to 400 mg daily) has demonstrated a lack of interference with the cardioprotective antiplatelet effect of aspirin (100 mg to 325 mg). Intervention: Concomitant use of celecoxib capsules and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see Warnings and Precautions (5.12) ]. Celecoxib is not a substitute for low dose aspirin for cardiovascular protection.

ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of ACE inhibitors, ARBs, or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

Intervention: During concomitant use of celecoxib capsules and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of celecoxib capsules and ACE inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [ see Warnings and Precautions (5.6) ] . When these drugs are administered concomitantly, patients should be adequately hydrated.

Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.

Intervention: During concomitant use of celecoxib with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [ see Warnings and Precautions (5.6) ]. Digoxin Clinical Impact: The concomitant use of Celecoxib with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of celecoxib capsules and digoxin, monitor serum digoxin levels.

Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal…

👥 Use in Specific Populations ~3 min read ▾

8. USE IN SPECIFIC POPULATIONS Infertility : NSAIDs are associated with reversible infertility. Consider withdrawal of celecoxib capsules in women who have difficulties conceiving ( 8.3 )

8.1Pregnancy Risk Summary Use of NSAIDs, including celecoxib capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of celecoxib capsules use between about 20 and 30 weeks of gestation and avoid celecoxib capsules use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations , Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including celecoxib capsules, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately 6 times the maximum recommended human dose (MRHD) of 200 mg twice daily.

In addition, structural abnormalities (e.g., septal defects, ribs fused, sternebrae fused and sternebrae misshapen) were observed in rabbits given daily oral doses of celecoxib during the period of organogenesis at approximately 2 times the MRHD (see Data ). Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as celecoxib, resulted in increased pre- and postimplantation loss.

Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including celecoxib capsules, can cause premature closure of the fetal ductus arteriosus ( see Data ).

Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If celecoxib capsules treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue celecoxib capsules and follow up according to clinical practice ( see Data ).

Labor or Delivery There are no studies on the effects of celecoxib during labor or delivery. In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data The available data do not establish the presence or absence of developmental toxicity related to the use of celecoxib capsules.

Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation a…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Use of NSAIDs, including celecoxib capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of celecoxib capsules use between about 20 and 30 weeks of gestation and avoid celecoxib capsules use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations , Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including celecoxib capsules, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately 6 times the maximum recommended human dose (MRHD) of 200 mg twice daily.

In addition, structural abnormalities (e.g., septal defects, ribs fused, sternebrae fused and sternebrae misshapen) were observed in rabbits given daily oral doses of celecoxib during the period of organogenesis at approximately 2 times the MRHD (see Data ). Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as celecoxib, resulted in increased pre- and postimplantation loss.

Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including celecoxib capsules, can cause premature closure of the fetal ductus arteriosus ( see Data ).

Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If celecoxib capsules treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue celecoxib capsules and follow up according to clinical practice ( see Data ).

Labor or Delivery There are no studies on the effects of celecoxib during labor or delivery. In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data The available data do not establish the presence or absence of developmental toxicity related to the use of celecoxib capsules.

Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published studies and postmarketing reports describe maternal N…

🆘 Overdosage 209 words ▾

10. OVERDOSAGE Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred.

Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ see Warnings and precautions (5.2 , 5.4 , 5.6) ]. No overdoses of celecoxib were reported during clinical trials. Doses up to 2,400 mg/day for up to 10 days in 12 patients did not result in serious toxicity.

No information is available regarding the removal of celecoxib by hemodialysis, but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes.

Consider emesis and/or activated charcoal (60 grams to 100 grams in adults, 1 gram to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro.

Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.

Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

12.2Pharmacodynamics Platelets In clinical trials using normal volunteers, celecoxib capsules at single doses up to 800 mg and multiple doses of 600 mg twice daily for up to 7 days duration (higher than recommended therapeutic doses) had no effect on reduction of platelet aggregation or increase in bleeding time. Because of its lack of platelet effects, celecoxib capsules are not a substitute for aspirin for cardiovascular prophylaxis. It is not known if there are any effects of celecoxib on platelets that may contribute to the increased risk of serious cardiovascular thrombotic adverse events associated with the use of celecoxib capsules.

Fluid Retention Inhibition of PGE2 synthesis may lead to sodium and water retention through increased reabsorption in the renal medullary thick ascending loop of Henle and perhaps other segments of the distal nephron. In the collecting ducts, PGE2 appears to inhibit water reabsorption by counteracting the action of antidiuretic hormone.

12.3Pharmacokinetics Celecoxib exhibits dose-proportional increase in exposure after oral administration up to 200 mg twice daily and less than proportional increase at higher doses. It has extensive distribution and high protein binding. It is primarily metabolized by CYP2C9 with a half-life of approximately 11 hours.

Absorption Peak plasma levels of celecoxib occur approximately 3 hours after an oral dose. Under fasting conditions, both peak plasma levels (C max ) and area under the curve (AUC) are roughly dose-proportional up to 200 mg twice daily; at higher doses there are less than proportional increases in C max and AUC [see Food Effects] . Absolute bioavailability studies have not been conducted.

With multiple dosing, steady-state conditions are reached on or before Day 5. The pharmacokinetic parameters of celecoxib in a group of healthy subjects are shown in Table 4. Table 4 Summary of Single Dose (200 mg) Disposition Kinetics of Celecoxib in Healthy Subjects Subjects under fasting conditions (n=36, 19 to 52 yrs.) Mean (%CV) PK Parameter Values C max , ng/mL T max , hr Effective t 1/2 , hr V ss /F, L CL/F, L/hr 705 (38) 2.8 (37) 11.2 (31) 429 (34) 27.7 (28) Food Effects When celecoxib capsules were taken with a high fat meal, peak plasma levels were delayed for about 1 to 2 hours with an increase in total absorption (AUC) of 10% to 20%.

Under fasting conditions, at doses above 200 mg, there is less than a proportional increase in C max and AUC, which is thought to be due to the low solubility of the drug in aqueous media. Coadministration of celecoxib capsules with an aluminum- and magnesium-containing antacids resulted in a reduction in plasma celecoxib concentrations with a decrease of 37% in C max and 10% in AUC. Celecoxib capsules, at doses up to 200 mg twice daily, can be administered without regard to timing of meals.

Higher doses (400 mg twice daily) should be administered with food to improve absorption. In healthy adult volunteers, the overall systemic exposure (AUC) of celecoxib was equivalent when celecoxib was administered as intact capsule or capsule contents sprinkled on applesauce. There were no significant alterations in C max , T max or t 1/2 after administration of capsule contents on applesauce [ see Dosage and Administration (2)…

🧬 Mechanism of Action 96 words ▾

12.1Mechanism of Action Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro.

Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.

Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

📦 How Supplied / Storage and Handling 194 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Celecoxib capsules, 50 mg are white, with reverse printed white on red band with markings SG on cap and 156 on body, supplied as: NDC Number Size 50228-156-30 bottle of 30 50228-156-60 bottle of 60 50228-156-10 bottle of 1,000 Celecoxib capsules, 100 mg are white, with reverse printed white on blue band with markings SG on cap and 157 on body, supplied as: NDC Number Size 50228-157-30 bottle of 30 50228-157-01 bottle of 100 50228-157-05 bottle of 500 50228-157-10 bottle of 1,000 Celecoxib capsules, 200 mg are white, with reverse printed white on gold band with markings SG on cap and 158 on body, supplied as: NDC Number Size 50228-158-30 bottle of 30 50228-158-01 bottle of 100 50228-158-05 bottle of 500 50228-158-10 bottle of 1,000 Celecoxib capsules, 400 mg are white, with reverse printed white on green band with markings SG on cap and 159 on body, supplied as: NDC Number Size 50228-159-30 bottle of 30 50228-159-60 bottle of 60 50228-159-05 bottle of 500 Storage: Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 199 words ▾

11. DESCRIPTION Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole.

The molecular weight is 381.38. Its molecular formula is C 17 H 14 F 3 N 3 O 2 S, and it has the following chemical structure: Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.

The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake.

100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake. structural formula

💬 Information for Patients ~3 min read ▾

17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with celecoxib capsules and periodically during the course of ongoing therapy.

Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [ see Warnings and Precautions (5.1) ]. Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [ see Warnings and Precautions (5.2) ].

Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop celecoxib and seek immediate medical therapy [ see Warnings and Precautions (5.3) , Use in Specific Populations (8.6) ]. Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [ see Warnings and Precautions (5.5) ].

Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [ see Contraindications (4) and Warnings and Precautions (5.7) ]. Serious Skin Reactions, including DRESS Advise patients to stop taking celecoxib capsules immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [ see Warnings and Precautions (5.9 , 5.10) ].

Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including celecoxib capsules, may be associated with a reversible delay in ovulation [ see Use in Specific Populations (8.3) ]. Fetal Toxicity Inform pregnant women to avoid use of celecoxib capsules and other NSAIDs starting at 30 weeks of gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with celecoxib capsules is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [ see Warnings and Precautions (5.11) and Use in Specific Populations (8.1) ].

Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of celecoxib capsules with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [ see Warnings and Precautions (5.2) and Drug Interactions (7) ]. Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia. Use of NSAIDS and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with celecoxib capsules until they talk to their healthcare provider [ see Drug Interactions (7) ].

Dispense the Medication Guide available at: https://sciegenpharm.com/medication-guide/ Manufactured By: ScieGen Pharmaceuticals, Inc. Hauppauge, New York 11788, USA Rev: 1/2026 Dispense the Medication Guide available at: https://sciegenpharm.com/medication-guide/

💬 Medication Guide ~3 min read ▾

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.

You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called “corticosteroids”, “antiplatelet drugs”, “anticoagulants”, “SSRIs” or “SNRIs” increasing doses of NSAIDs older age longer use of NSAIDs poor health smoking advanced liver disease drinking alcohol bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery.

Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby.

You should not take NSAIDs after about 30 weeks of pregnancy are breastfeeding or plan to breast feed. Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects.

Do not start taking any new medicine without talking to your healthcare provider first. What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?" new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing slurred speech chest pain swelling of the face or throat weakness in one part or side of your body Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: • nausea • vomit blood • more tired or weaker than usual • there is blood in your bowel movement or it is black and sticky like tar • diarrhea • itching • unusual weight gain • your skin or eyes look yellow • skin rash or blisters with fever • indigestion or stomach pain • swelling of the arms, legs, hands and feet • flu-like…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.