Prescription drug · ANDA
Famotidine NDC 68071-3521
Famotidine 40 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3521-3 | 68071352103 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3521-3)Marketed from Oct 12, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Famotidine
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216441
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68071-3521_2d3f8242-1bd2-44b6-e063-6394a90a1a32SPL ID 2d3f8242-1bd2-44b6-e063-6394a90a1a32SPL set ID 0786d7f5-85a7-d835-e063-6394a90ad719RxCUI 284245UNII 5QZO15J2Z8UPC 0368071352139
- 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
N468071352103followed by a unit qualifier and the quantityPackage 68071-3521-03. 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)
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence. Famotidine is a histamine-2 (H 2 ) receptor antagonist indicated ( 1 ): In adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer. sympto…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216441
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 |
|---|---|---|---|---|
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-736 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1702 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1703 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9615 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2190 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1683 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1684 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-150 |