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Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated, 100-count — NDC 65862-191-01 (Billing 65862-0191-01)

by Aurobindo Pharma Limited · 100 TABLET, FILM COATED in 1 BOTTLE

This is a package of 100 tablets of Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated from Aurobindo Pharma Limited, marketed since Sep 2008 and currently FDA-listed.

NDC 65862-0191-01
🏷️ FDA NDC (as labeled) 65862-191-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1547/unit — full pricing hub ↓
Product page 65862-0191-05 Also comes in: 500 tablets 65862-191-05 1000 tablets 65862-191-99 8000 tablets 65862-191-81
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 65862-191-01 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
65862 labeler · 191 product · 01 package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 6586219101 4
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Cyclobenzaprine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Aug 27, 2025 — Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). (Unichem Pharmaceuticals USA Inc.) · FDA recall D-0655-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65862-191-01
Product NDC 65862-191
11-digit billing NDC 65862019101
NCPDP billing unit EA — each (per item)
SPL Set ID 3b8db13a-0db8-446a-a391-f3f1573d96fb
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-09-26
Dosage form TABLET, FILM COATED
Substance CYCLOBENZAPRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 75100050100305
GPI class Cyclobenzaprine HCl
GCN Seq No 004681
GCN 18020
HICL code 001950
Ingredient (HICL) Cyclobenzaprine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.04.00
AHFS class Centrally Acting Skeletal Muscle Relaxnt
FDB label name CYCLOBENZAPRINE 10 MG TABLET
FDB brand name Cyclobenzaprine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004681
  • GCN: 18020
  • GPI-14 (Medi-Span): 75100050100305
  • HICL (First Databank): 001950
  • AHFS class code: 12:20.04.00
Why two NDCs? The FDA registers this code as 65862-191-01 — 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 → 65862-0191-01. 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.

Clinical

Label name CYCLOBENZAPRINE 10 MG TABLET Ingredient Cyclobenzaprine Hcl
📗 Our plain-language guide HelloPharmacist
  • Cyclobenzaprine tablets and extended-release capsules ease muscle spasm from recent, painful muscle or joint problems. You use them with rest and physical therapy. Tonmya, a differ...
  • For muscle spasm, it's meant for short-term use only, about two or three weeks. Spasms usually improve in that time, and there's no good evidence it works longer.
  • Dry mouth, drowsiness, dizziness, tiredness, constipation and nausea are the most common. Be careful driving until you know how it affects you. Call your doctor if side effects bot...
  • Alcohol and other sedating medicines can make it stronger, so avoid mixing them. Tell me about any antidepressants, tramadol or other related medicines, because of the risk of sero...
📖 Read our full Cyclobenzaprine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1547 $15.47 / 100 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
65862-0191-01 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE — — 2008-09-26 — Active
65862-0191-05 65862-191-05 Main listing 500 TABLET, FILM COATED in 1 BOTTLE $0.0171 / ea $8.56 2008-09-26 — Active
65862-0191-99 65862-191-99 1000 TABLET, FILM COATED in 1 BOTTLE — — 2008-09-26 — Active
65862-0191-81 65862-191-81 8000 TABLET, FILM COATED in 1 BAG — — — — Active

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

This pack shows little to no recent Medicaid volume — the 500 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, film coated in 1 bottle.
How does this package differ from NDC 65862-0191-05?
Both are Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 65862-0191-05 is the 500 tablets package.
What NDC number is used to bill for this package of Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cyclobenzaprine Hydrochloride 10 mg 00093-3422-01 Teva 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 00904-7401-61 Major 1 tablet $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 16571-0783-01 Rising 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine hydrochloride 10 mg 29300-0415-01 Unichem 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 50268-0191-15 AvPAK 1 tablet $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 52817-0332-00 TruPharma 1000 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 59746-0177-06 Jubilant 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 60687-0558-01 American 1 tablet $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 64980-0657-01 Rising 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 69097-0846-07 Cipla 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 70512-0872-10 SOLA 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 72603-0312-01 NORTHSTAR 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 72888-0014-00 Advagen 1000 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 76282-0283-10 EXELAN 1000 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 10702-0007-01 KVK-TECH, 100 tablets $0.022 AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 00615-8084-05 NCS 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 42291-0154-10 AvKARE 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 43547-0400-01 Solco 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 45865-0244-14 Medsource 14 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4722-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4727-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4729-01 A-S 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4730-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5711-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5712-00 A-S 3 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5713-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5772-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-6864-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0539-20 Northwind 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0592-20 Northwind 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0973-87 Northwind 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 53746-0541-01 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 55154-0190-00 Cardinal 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 60760-0767-04 ST. 4 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 62332-0647-31 Alembic 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63187-0157-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63187-0812-07 Proficient 7 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-1209-01 Bryant 1000 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 63629-1210-01 Bryant 500 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-1211-01 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-9297-01 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 65162-0541-10 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mgthis 65862-0191-01 Aurobindo 100 tablets — — FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67046-1566-03 Coupler 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67046-1645-03 Coupler 30 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 67296-1441-01 Redpharm 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-1893-03 Redpharm 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-2084-01 Redpharm 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-2659-03 NuCare 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3150-01 NuCare 21 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3154-01 NuCare 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3404-03 NuCare 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3462-02 NuCare 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3561-04 NuCare 4 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3627-05 NuCare 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3973-07 NuCare 14 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3981-06 NuCare 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-4935-06 NuCare 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-4951-02 NuCare 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-8167-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-8474-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 68788-8637-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 69306-0872-03 Doc 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 70518-3415-00 REMEDYREPACK 30 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 70518-3474-00 REMEDYREPACK 1 tablet — AB Discontinued —
Cyclobenzaprine hydrochloride 10 mg 70518-3702-00 REMEDYREPACK 60 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 70518-3764-00 REMEDYREPACK 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71205-0065-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71205-0201-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-1266-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 71335-1962-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2110-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2492-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2666-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2678-01 Bryant 5 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2686-01 Bryant 5 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0016-30 Aphena 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0428-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0907-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0933-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72162-1359-00 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72189-0080-07 DIRECT 7 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72189-0545-15 Direct_Rx 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0036-01 PD-Rx 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0046-03 PD-Rx 3 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0156-15 PD-Rx 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0011-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0033-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0271-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0599-02 Asclemed 2 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0830-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 76420-0841-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine HCL 10 mg 80425-0018-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0019-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0498-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0547-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 82461-0716-90 Medcore 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 82804-0259-30 Proficient 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85509-1014-03 PHOENIX 30 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 85509-1415-03 PHOENIX 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85766-0003-00 Sportpharm 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85766-0041-00 Sportpharm 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 87441-0010-01 Unit 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85534-0086-00 HAWAII 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 70518-4692-00 REMEDYREPACK 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-4154-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-2306-02 Redpharm 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 00615-8665-05 NCS 15 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 85766-0274-01 Sportpharm 100 tablets — AB FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2008
On the market since
Sep 2008
📍
2026
Currently FDA-listed
18 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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.

🧪 Avoiding an ingredient? See Cyclobenzaprine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerAurobindo Pharma Limited
Labeler code65862
First marketedSep 2008
Product typeDrug For Further Processing
Portfolio1,464 products on file

More NDCs from Aurobindo Pharma Limited labeler code 65862

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.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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.
500 tablets65862-0191-05 310,887 Rx · $1,950,774
100 tablets this page65862-0191-01 No Medicaid data
1000 tablets65862-0191-99 No Medicaid data
8000 tablets65862-0191-81 No Medicaid data
Drug total (last 4 qtrs): 310,887 Rx · 13,766,499 units · $1,950,774 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Aurobindo Pharma Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aurobindo Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 500 tablets (65862-0191-05), 1000 tablets (65862-0191-99), 8000 tablets (65862-0191-81). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aurobindo Pharma Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 65862-0190-01 · Aurobindo 65862-0192-01 · Aurobindo →
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.