Famotidine
- Product NDC
- 71335-9615
- 11-digit product format
- 713359615
- Labeler code
- 71335
- Product ID
- 71335-9615_f1427287-ee2e-4e22-9fed-68f0e03cc9ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA216441
- Marketing category
- ANDA
- Marketing start
- 2022-06-06
- Substance
- FAMOTIDINE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-9615_f1427287-ee2e-4e22-9fed-68f0e03cc9ea
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Famotidine
- Generic name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2022-06-06
- Marketing category
- ANDA
- Application number
- ANDA216441
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA]; Histamine-2 Receptor Antagonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| FAMOTIDINE | 40 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 284245 |
| Spl Set Id | 8dc075fe-a3e5-4710-8c19-73558a8c5f09 |
| Manufacturer Name | Bryant Ranch Prepack |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 5QZO15J2Z8 | FAMOTIDINE | 76824-35-6 | FAMOTIDINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-9615-1 | 71335961501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9615-1) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9615-2 | 71335961502 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9615-2) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9615-3 | 71335961503 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9615-3) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9615-4 | 71335961504 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9615-4) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9615-5 | 71335961505 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-9615-5) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9615-6 | 71335961506 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-9615-6) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9615-7 | 71335961507 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-9615-7) | 2023-01-03 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Famotidine | Bryant Ranch Prepack | 2024-08-23 | HUMAN PRESCRIPTION DRUG LABEL | 102 |