Over-the-counter drug · ANDA
heartburn relief original strength NDC 0904-5529
famotidine · Famotidine 10 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-5529-52 | 00904552952 | 1 BOTTLE in 1 CARTON (0904-5529-52) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 9, 2009 | |
| 0904-5529-87 | 00904552987 | 30 BLISTER PACK in 1 CARTON (0904-5529-87) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 9, 2009 |
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)
- heartburn relief original strengthSuffix: original strength
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075400
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0904-5529_4bbca900-8593-427c-8595-c5c6c3456967SPL ID 4bbca900-8593-427c-8595-c5c6c3456967SPL set ID be275c48-18bf-45f6-891d-36d89327813eRxCUI 199047UNII 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
N400904552952followed by a unit qualifier and the quantityPackage 00904-5529-52. 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.
Other NDCs under ANDA 075400
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 |
|---|---|---|---|---|
| Acid Controller Original Strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-0141 |
| Equate Famotidinefamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-507 |
| acid controllerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | H E B | 37808-301 |
| acid controller original strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-141 |
| heartburn relief original strengthfamotidine | Famotidine 10 mg/1 | TabletOral | Proficient Rx LP | 63187-999 |
| Acid Reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-816 |
| Acid Reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-756 |
| basic care acid reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-141 |
| foster and thrive acid reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1102 |
| acid reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-141 |
| CareOne Acid Relieffamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-901 |
| acid relieffamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-6141 |
| equaline heartburn preventionfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-313 |
| TopCare Acid Reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-141 |
| Acid Controllerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Safeway | 21130-771 |
| dg health heartburn prevention original strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Dolgencorp, LLC | 55910-141 |
| heartburn relieffamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-493 |
| signature care acid controllerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Safeway | 21130-249 |
| acid reducer original strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-141 |
| good sense acid reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0141 |