Prescription drug · ANDA
Famotidine NDC 46708-294
Famotidine 40 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-294-10 | 46708029410 | 100 TABLET in 1 CARTON (46708-294-10)Marketed from Jan 29, 2016 | |
| 46708-294-30 | 46708029430 | 30 TABLET in 1 BOTTLE (46708-294-30)Marketed from Jan 29, 2016 | |
| 46708-294-31 | 46708029431 | 100 TABLET in 1 BOTTLE (46708-294-31)Marketed from Jan 29, 2016 | |
| 46708-294-71 | 46708029471 | 500 TABLET in 1 BOTTLE (46708-294-71)Marketed from Jan 29, 2016 | |
| 46708-294-91 | 46708029491 | 1000 TABLET in 1 BOTTLE (46708-294-91)Marketed from Jan 29, 2016 |
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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078916
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 46708-294_02d57009-ba37-4b5d-af59-7a62f1d9e29cSPL ID 02d57009-ba37-4b5d-af59-7a62f1d9e29cSPL set ID 7c0f3fa5-0a44-4a98-bc43-8bff8e95c462RxCUI 284245, 310273UNII 5QZO15J2Z8UPC 0346708294304, 0346708293307
- 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
N446708029410followed by a unit qualifier and the quantityPackage 46708-0294-10. 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)
INDICATIONS AND USAGE Famotidine is indicated in: 1. Short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. 3. Short-term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078916
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 | TabletOral | Bryant Ranch Prepack | 71335-0409 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | direct rx | 72189-141 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3201 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Proficient Rx LP | 63187-723 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-293 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-077 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-001 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-002 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4119 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-399 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Proficient Rx LP | 63187-908 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0231 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8558 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8559 |