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Pseudoephedrine Hydrochloride 60 mg Tablet, 30-count — NDC 00904-6728-46 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pseudoephedrine Hydrochloride 60 mg Tablet, 30-count — NDC 0904-6728-46 (Billing 00904-6728-46)

by Major Pharmaceuticals · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Pseudoephedrine Hydrochloride 60 mg Tablet from Major Pharmaceuticals, marketed since Aug 2019 and currently FDA-listed; retail pharmacies pay about $0.0775 per tablet (NADAC).

NDC 00904-6728-46
🏷️ FDA NDC (as labeled) 0904-6728-46 billing pads the labeler segment with a zero
This package
Contains30-count Cost per ea$0.0775 NADAC Per package$2.33 / 30 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2030/unit — full pricing hub ↓
Product page 00904-6728-52 Also comes in: 100 tablets 0904-6728-52
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 0904-6728-46 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0904 labeler · 6728 product · 46 package
Package marketed since
Aug 29, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 0904672846 7
Medicaid fills, this package
2,795 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0904-6728-46
Product NDC 0904-6728
11-digit billing NDC 00904672846
NCPDP billing unit EA — each (per item)
Application # M012
SPL Set ID 78fc7358-75d1-e94a-e053-2a91aa0ab0f1
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-26
Route ORAL
Dosage form TABLET
Substance PSEUDOEPHEDRINE HYDROCHLORIDE

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

GCN Seq No 005090
GCN 20482
HICL code 002091
Ingredient (HICL) Pseudoephedrine Hcl
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B6
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code B6V
Therapeutic class — specific (HIC3) Decongestants, Oral
AHFS code 12:12.12.00
AHFS class Alpha- And Beta-Adrenergic Agonists
FDB label name SUDOGEST 60 MG TABLET
FDB brand name Sudogest
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 005090
  • GCN: 20482
  • HICL (First Databank): 002091
  • AHFS class code: 12:12.12.00
Why two NDCs? The FDA registers this code as 0904-6728-46 — a 4-4-2 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 labeler segment → 00904-6728-46. 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 SUDOGEST 60 MG TABLET Ingredient Pseudoephedrine Hcl
📖 What it is MedlinePlus · NLM

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves nasal congestion from the common cold, hay fever or other upper respiratory allergies. Many products also relieve sinus congestion and pressure.
  • It depends on the product. Regular tablets and softgels are usually taken every 4 to 6 hours, while 12-hour extended-release tablets are taken every 12 hours. Check your box for th...
  • No. Swallow them whole. Don't divide, crush, chew or dissolve them. Seeing part of the tablet in your stool can happen and is normal.
  • Can I crush or chew the extended-release tablets?
📖 Read our full Pseudoephedrine 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 eaPer package
Retail pharmacies payNADAC · weekly $0.078 $2.33 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $0.2030 $6.09 / 30 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.079 $0.043
▲ Up 70% 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00904-6728-46 You're viewing this 30 TABLET in 1 BOTTLE $0.0775 / ea $2.32 2019-08-29 — Active
00904-6728-52 0904-6728-52 Main listing 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE $0.0775 / ea $7.75 2019-08-26 — Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0775 NADAC).

This pack accounts for about 24% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet in 1 bottle.
How does this package differ from NDC 00904-6728-52?
Both are Pseudoephedrine Hydrochloride 60 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 00904-6728-52 is the 100 tablets package.
What NDC number is used to bill for this package of Pseudoephedrine Hydrochloride 60 mg Tablet?
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
Pseudoephedrine Hydrochloride 60 mgthis 00904-6728-46 Major 30 tablets $0.077 — Availability likely —
Pseudoephedrine Hydrochloride 60 mg 00904-6907-06 Major 50 tablets $0.077 — Availability likely —
Pseudoephedrine Hydrochloride 60 mg 50090-4546-00 A-S 24 tablets — — Discontinued —
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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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.

What it looks like

Color white
ShapeRound
ImprintCPC
Size8 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 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 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statescroscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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.

Manufacturer & labeler

LabelerMajor Pharmaceuticals
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedAug 2019
Product typeHuman Otc Drug
Portfolio630 products on file

More NDCs from Major Pharmaceuticals labeler code 00904

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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

⏱️ Dosage and Administration 35 words ▾

Directions adults and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours. children under 12 years of age: do not use

⚠️ Warnings 143 words ▾

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose.

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

🆘 Overdosage 15 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 11 words ▾

Drug Facts Active ingredient (in each tablet) Pseudoephedrine HCl 60 mg

🧪 Inactive Ingredients 11 words ▾

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid.

🎯 Purpose 3 words ▾

Purpose Nasal decongestant

📄 Do Not Use 55 words ▾

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

📄 Ask a Doctor Before Use If 24 words ▾

Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dose.

📄 Stop Use and Ask a Doctor If 24 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 20 words ▾

Other information store in a dry place at 15° – 30°C (59° – 86°F) use by expiration date on package

📄 Questions or Comments 5 words ▾

Questions or comments? (800) 231-4670

📄 Package Label / Principal Display Panel 30 words ▾

MAJOR NDC 0904-6728-46 SudoGest TM Nasal Decongestant Pseudoephedrine Hydrochloride 60 mg Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness 30 Tablets Major Label Major Label

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

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 this package alone, 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 – Q1 2026 · 5 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
2.8K
Units reimbursed last 4 qtrs
77.7K
Gross reimbursed last 4 qtrs
$15.8K
Avg / prescription
$5.64
Avg / unit
$0.2030
Latest quarter Q1 2026
949Rx
Medicaid pays / ea
$0.2030
gross reimbursed
vs
NADAC / ea
$0.0775
acquisition cost
=
Spread
+$0.1255
+162% 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 ⓘ
96% MCO
Fee-for-service · 119 Rx Managed care · 2,676 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 8,920 units · 114 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,579 units · 27.5 per 100k residents MN Wisconsin: 1,163 units · 19.7 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 17,080 units · 403 per 100k residents OR Nevada: 977 units · 30.6 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,489 units · 46.4 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 13,251 units · 112 per 100k residents OH Pennsylvania: 1,906 units · 14.7 per 100k residents PA New Jersey: 5,582 units · 60.1 per 100k residents NJ Massachusetts: 1,414 units · 20.2 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 796 units · 40.2 per 100k residents NE Missouri: no data reported MO Kentucky: 16,051 units · 355 per 100k residents KY West Virginia: no data reported WV Virginia: 1,270 units · 14.6 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: 366 units · 33.4 per 100k residents RI Arizona: 4,258 units · 57.3 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 320 units · 22.3 per 100k residents HI Texas: 1,275 units · 4.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.2403
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 Oregon 403 /100k
2 Kentucky 355 /100k
3 Washington 114 /100k
4 Ohio 112 /100k
5 New Jersey 60.1 /100k
6 Arizona 57.3 /100k
7 Iowa 46.4 /100k
8 Nebraska 40.2 /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 tablets00904-6728-52 8,930 Rx · $161,256
30 tablets this page00904-6728-46 2,795 Rx · $15,774
Drug total (last 4 qtrs): 11,725 Rx · 349,597 units · $177,029 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 00904-6727-60 · Major 00904-6730-59 · Major →
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.