Prescription drug · ANDA
Famotidine NDC 85534-0091
Famotidine 20 mg/1 · Tablet, Film coated · Oral · HAWAII REPACK, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85534-0091-0 | 85534009100 | 30 TABLET, FILM COATED in 1 BOTTLE (85534-0091-0)Marketed from Jul 13, 2026 | |
| 85534-0091-1 | 85534009101 | 60 TABLET, FILM COATED in 1 BOTTLE (85534-0091-1)Marketed from Jul 13, 2026 | |
| 85534-0091-2 | 85534009102 | 90 TABLET, FILM COATED in 1 BOTTLE (85534-0091-2)Marketed from Jul 13, 2026 | |
| 85534-0091-3 | 85534009103 | 120 TABLET, FILM COATED in 1 BOTTLE (85534-0091-3)Marketed from Jul 13, 2026 |
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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- HAWAII REPACK, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215630
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 85534-0091_567abb69-f223-aaf0-e063-6394a90a4679SPL ID 567abb69-f223-aaf0-e063-6394a90a4679SPL set ID eec89230-47fc-4139-a370-b4f9e225e8c0RxCUI 284245, 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
N485534009100followed by a unit qualifier and the quantityPackage 85534-0091-00. 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 (H2) receptor antagonist indicated (1) : In adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer. symptomat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215630
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 | HAWAII REPACK, INC. | 85534-0092 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8485 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-843 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-842 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-889 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8518 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3829 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-713 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-712 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-345 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7982 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2442 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7981 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | NuCare Pharmceuticals,Inc. | 68071-3413 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-843 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3420 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4574 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4084 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6582 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-453 |
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