Prescription drug · ANDA
Famotidine NDC 68001-397
Famotidine 20 mg/1 · Tablet, Film coated · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-397-00 | 68001039700 | 100 TABLET, FILM COATED in 1 BOTTLE (68001-397-00)Marketed from Jun 19, 2019 | |
| 68001-397-08 | 68001039708 | 1000 TABLET, FILM COATED in 1 BOTTLE (68001-397-08)Marketed from Jun 19, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Famotidine
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- BluePoint Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206530
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68001-397_bfda441a-c4ae-7bf3-e053-2a95a90adfe2SPL ID bfda441a-c4ae-7bf3-e053-2a95a90adfe2SPL set ID 8c7ca3cc-ff90-42a7-9218-554cf15348a3RxCUI 284245, 310273UNII 5QZO15J2Z8UPC 0368001398008
- 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
N468001039700followed by a unit qualifier and the quantityPackage 68001-0397-00. 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 gastric ulcer. symptom…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206530
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 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-535 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-398 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-030 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0370 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-634 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-595 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-859 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-860 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6916 |