Prescription drug · ANDA
Famotidine NDC 70518-4394
Famotidine 40 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4394-0 | 70518439400 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4394-0)Marketed from Jul 18, 2025 |
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
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217400
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70518-4394_5b129e06-e722-6e90-e063-6394a90a3944SPL ID 5b129e06-e722-6e90-e063-6394a90a3944SPL set ID 669fbd46-cae5-4477-884e-8eca893d2e05RxCUI 284245UNII 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
N470518439400followed by a unit qualifier and the quantityPackage 70518-4394-00. 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 (H 2 ) receptor antagonist indicated ( 1 ): In adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217400
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 | Preferred Pharmaceuticals Inc. | 68788-4144 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2805 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-145 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-146 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2186 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4021 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0589 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4395 |