Over-the-counter drug · ANDA
Major Heartburn Relief Maximum Strength (Famotidine) NDC 0904-5780
Famotidine 20 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-5780-17 | 0090457801700904578017 | 25 BLISTER PACK in 1 CARTON (0904-5780-17) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 4, 2006 | |
| 0904-5780-51 | 0090457805100904578051 | 1 BOTTLE in 1 CARTON (0904-5780-51) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 29, 2006 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Major Heartburn Relief Maximum StrengthSuffix: Maximum Strength
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077351
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0904-5780_2b99e188-08ce-4160-bf19-136bc4dd39beSPL ID 2b99e188-08ce-4160-bf19-136bc4dd39beSPL set ID ee0a263e-3f78-4534-9a30-803de636f92bRxCUI 310273UNII 5QZO15J2Z8
- Pharmacologic class
- Histamine-2 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400904578017followed by a unit qualifier and the quantityPackage 00904-5780-17. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses • relieves heartburn associated with acid indigestion and sour stomach • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Excerpt only. Read the full label for complete information.
About NDC 0904-5780
- What is NDC 0904-5780?
- 0904-5780 is the product NDC for Major Heartburn Relief Maximum Strength, Famotidine 20 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Major Heartburn Relief Maximum Strength (Famotidine).
- What is the active ingredient?
- Famotidine.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Major Heartburn Relief Maximum Strength?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 077351
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| dg health heartburn preventionfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-665 |
| careone acid relieffamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Retail Business Services, LLC | 72476-299 |
| acid controllerfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1203 |
| heartburn relieffamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-712 |
| basic care heartburn preventionfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-151 |
| Acid Reducerfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-511 |
| CareOne Acid Relieffamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-707 |
| basic care acid reducerfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-194 |
| acid reducerfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 69842-659 |
| equate famotidinefamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-115 |
| Rolaids ACID DEFENSEfamotitine | Famotidine 20 mg/1 | TabletOral | The Procter & Gamble Manufacturing Company | 84126-367 |
| dg health acid reducerfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-814 |
| dg health heartburn preventionfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-194 |
| Acid Controllerfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-0701 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Precision Dose, Inc. | 68094-054 |
| members mark acid pepfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Sam's West Inc | 68196-121 |
| berkley and jensen famotidinefamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | BJWC | 68391-300 |
| heartburn preventionfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Kroger Company | 30142-194 |
| basic care acid reducerfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-329 |
| Equate Famotidinefamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-650 |
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