Home › NDC Lookup › Ingredients › Guaifenesin And Dextromethorphan Hbr › 63304-0106-21
⚪image loading
(from DailyMed)

Guaifenesin and Dextromethorphan HBr 600 mg; 30 mg Tablet, Extended Release, 20-count — NDC 63304-106-21 (Billing 63304-0106-21)

by SUN PHARMACEUTICAL INDUSTRIES, INC. · 1 BLISTER PACK in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

This is a package of 20 tablets of Guaifenesin and Dextromethorphan HBr 600 mg; 30 mg Tablet, Extended Release from SUN PHARMACEUTICAL INDUSTRIES, INC., marketed since Jul 2021 and currently FDA-listed. It is this product's only package size.

NDC 63304-0106-21
🏷️ FDA NDC (as labeled) 63304-106-21 billing pads the product segment with a zero
OTC Generic 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63304-106-21
Product NDC 63304-106
11-digit billing NDC 63304010621
RxCUI 1099074, 1298324
UNII 495W7451VQ, 9D2RTI9KYH
Application # ANDA214781
SPL Set ID 06328741-03e3-49cf-ae44-d4c2116e38a3
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-01
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 1099074
Why two NDCs? The FDA registers this code as 63304-106-21 — 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 → 63304-0106-21. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It helps loosen mucus and makes coughs more productive. It also temporarily eases cough from minor throat and bronchial irritation, like with a cold or inhaled irritants.
  • Swallow them whole with a full glass of water. Don’t crush, chew or break them. You can take them with or without food, about every 12 hours as your label directs.
  • How do I take the extended-release tablets?
  • The extended-release tablets are not for children under 12. Some liquid products are made for children, so check that product’s label and ask me if you’re unsure.
📖 Read our full Dextromethorphan / Guaifenesin 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 Marketing startMarketing endStatus
63304-0106-21 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2021-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mucus Relief DM Extended Release Caplets 600 mg/1; 30 mg 00536-1161-34 Rugby 20 tablets $0.356 — Availability likely —
Rugby Mucus Relief DM ER 30 mg/1; 600 mg 00536-1446-34 Rugby 20 tablets $0.356 — Availability likely —
Good Neighbor Pharmacy Mucus Dm 30 mg/1; 600 mg 46122-0817-61 Amerisource 20 tablets $0.356 — Availability likely —
Leader Mucus Relief DM 30 mg/1; 600 mg 70000-0722-01 Cardinal 20 tablets $0.356 — Availability likely —
Mucus Relief DM 600 mg/1; 30 mg 70677-1050-01 Strategic 1 tablet $0.356 — Availability likely —
Mucus Relief DM 600 mg/1; 30 mg 70000-0491-01 CARDINAL 20 tablets $0.359 — Discontinued —
Mucinex DM 600 mg/1; 30 mg 63824-0056-01 Reckitt 20 tablets $0.608 — Discontinued —
Good Sense Mucus DM 30 mg/1; 600 mg 00113-2219-01 L. 20 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 00363-0474-01 WALGREEN 10 tablets — — FDA listed —
Mucus Relief DM Extended Release Caplets 600 mg/1; 30 mg 00363-0733-20 Walgreens 20 tablets — — FDA listed —
Mucus Relief DM 30 mg/1; 600 mg 00363-3219-01 Walgreen 20 tablets — — FDA listed —
up and up mucus relief dm 30 mg/1; 600 mg 11673-0716-01 Target 20 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 11822-0733-02 Rite 20 tablets — — FDA listed —
mucus relief DM 30 mg/1; 600 mg 11822-2219-00 Rite 20 tablets — — FDA listed —
Mucus Relief DM Extended Release Caplets 600 mg/1; 30 mg 17856-1162-01 ATLANTIC 1 tablet — — FDA listed —
Mucus Relief Dm 600 mg/1; 30 mg 21130-0997-67 Better 10 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 30142-0276-20 KROGER 10 tablets — — FDA listed —
Guaifenesin And Dextromethorphan Hbr 600 mg/1; 30 mg 30142-0948-20 Kroger 20 tablets — — FDA listed —
Topcare Mucus DM 30 mg/1; 600 mg 36800-0219-01 Topco 20 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 37808-0733-40 H 40 tablets — — FDA listed —
equaline mucus dm 30 mg/1; 600 mg 41163-0599-01 United 20 tablets — — FDA listed —
mucus relief dm 30 mg/1; 600 mg 41250-0436-01 Meijer 20 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 41415-0998-20 PUBLIX 20 tablets — — FDA listed —
Mucus Dm 30 mg/1; 600 mg 42507-0222-20 HyVee 20 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBR 600 mg/1; 30 mg 43598-0114-01 Dr. 20 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBR 600 mg/1; 30 mg 43598-0231-01 Dr. 20 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 49035-0960-12 Wal-Mart 40 tablets — — FDA listed —
Mucinex Dm 600 mg/1; 30 mg 50090-1077-00 A-S 20 tablets — — FDA listed —
Mucinex DM 600 mg/1; 30 mg 50090-1078-00 A-S 20 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBR 600 mg/1; 30 mg 51316-0009-01 CVS 20 tablets — — FDA listed —
Cough And Congestion Extended Release 600 mg/1; 30 mg 51316-0065-67 CVS 10 tablets — — FDA listed —
Mucus Relief Dm 30 mg/1; 600 mg 51316-0858-78 CVS 100 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 51660-0301-21 OHM 20 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 55910-0733-06 Dolgencorp, 6 tablets — — FDA listed —
DG health mucus dm 30 mg/1; 600 mg 55910-0746-01 Dolgencorp 20 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 58602-0714-05 Aurohealth 14 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 58602-0824-08 Aurohealth 10 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 58602-0871-83 Aurohealth 10 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 59726-0733-06 P 6 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 60000-0058-67 Ahold 20 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mgthis 63304-0106-21 SUN 20 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 63941-0733-20 Best 20 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 65162-0038-03 Amneal 30 tablets — — FDA listed —
Mucinex DM, TRAVEL BASIX 600 mg/1; 30 mg 66715-6424-01 Lil' 2 tablets — — FDA listed —
Mucinex DM, CVP HEALTH 600 mg/1; 30 mg 66715-6524-01 Lil' 2 tablets — — FDA listed —
Mucinex DM 600 mg/1; 30 mg 66715-9724-01 Lil' 2 tablets — — FDA listed —
Mucus Relief DM Expectorant and Cough Suppressant 600 mg/1; 30 mg 67091-0314-20 Winco 10 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 67091-0344-20 WinCo 20 tablets — — FDA listed —
Mucinex DM 30 mg/1; 600 mg 67751-0171-01 Navajo 2 tablets — — FDA listed —
Mucus DM Extended Release 600 mg/1; 30 mg 69842-0057-11 CVS 10 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 69842-0933-20 CVS 20 tablets — — Discontinued —
mucus dm extended release 30 mg/1; 600 mg 69842-0963-01 CVS 20 tablets — — FDA listed —
Mucus Relief Dm 600 mg/1; 30 mg 72036-0012-20 Harris 10 tablets — — FDA listed —
basic care mucus dm 30 mg/1; 600 mg 72288-0219-49 Amazon.com 40 tablets — — FDA listed —
Amazon Basic Care Mucus Dm 600 mg/1; 30 mg 72288-0220-08 Amazon.com 10 tablets — — FDA listed —
Mucus Relief DM 600 mg/1; 30 mg 72476-0733-20 Care 20 tablets — — FDA listed —
equate mucus relief dm 30 mg/1; 600 mg 79903-0065-01 WALMART 20 tablets — — FDA listed —
Mucinex DM 600 mg/1; 30 mg 85237-1650-01 Select 2 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 85766-0150-14 Sportpharm 14 tablets — — FDA listed —
Good Sense Mucus DM 30 mg/1; 600 mg 85766-0172-20 Sportpharm 20 tablets — — FDA listed —
Mucinex DM 600 mg/1; 30 mg 85766-0176-20 Sportpharm 20 tablets — — 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

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 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.

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 HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • 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.

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

The official label also statescarbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), 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

LabelerSUN PHARMACEUTICAL INDUSTRIES, INC.
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA214781 (ANDA)
Labeler code63304
First marketedJul 2021
Product typeHuman Otc Drug
Portfolio890 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.

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 61 words ▾

Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help you get to sleep

⏱️ Dosage and Administration 70 words ▾

Directions • do not crush, chew, or break extended-release tablet • take with a full glass of water • this product can be administered without regard for timing of meals • adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours • children under 12 years of age: do not use Other information • Store between 20-25°C (68-77°F)

⚠️ Warnings 175 words ▾

Warnings Do not use • for children under 12 years of age • 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 • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) When using this product • Do not use more than directed Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness. Pregnancy or Breast Feeding 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 (1-800-222-1222).

🧪 Active Ingredient 13 words ▾

Active ingredients (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 1200 mg

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

🎯 Purpose 4 words ▾

Purposes Cough suppressant Expectorant

📄 Ask a Doctor Before Use If 31 words ▾

Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus)

📄 When Using This Product 11 words ▾

When using this product • Do not use more than directed

📄 Stop Use and Ask a Doctor If 32 words ▾

Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

🤰 If Pregnant or Breast-Feeding 14 words ▾

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

📄 Keep Out of Reach of Children 22 words ▾

Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📄 Package Label / Principal Display Panel 82 words ▾

Package/Label Principal Display Panel NDC 63304-110-14 Maximum Strength Guaifenesin & Dextromethorphan HBr Extended-Release Tablets 1200 mg/60 mg Expectorant & Cough Suppressant 12 Hour • Controls Cough • Thins and Loosens Mucus • Immediate and Extended Release 14 Extended-Release Tablets SUN PHARMA spl-guai-dextro-label

Package/Label Principal Display Panel NDC 63304-106-21 Guaifenesin & Dextromethorphan HBr Extended-Release Tablets 600 mg/30 mg Expectorant & Cough Suppressant 12 Hour • Controls Cough • Thins and Loosens Mucus • Immediate and Extended Release 20 Extended-Release Tablets SUN PHARMA spl-guai-dextro-label2

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

About this NDC listing & data coverage

Over-the-counter (OTC) product
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) ✓ 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

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 SUN PHARMACEUTICAL INDUSTRIES, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SUN PHARMACEUTICAL INDUSTRIES, INC. 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.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 63304-0104-90 · Sun 63304-0110-54 · SUN →
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.