FAMOTIDINE
- Product NDC
- 76420-713
- 11-digit product format
- 764200713
- Labeler code
- 76420
- Product ID
- 76420-713_15e01bf2-c2eb-f176-e063-6294a90a5d21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FAMOTIDINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA215630
- Marketing category
- ANDA
- Marketing start
- 2023-08-23
- 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
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 | Sample | Exclude flag | Status |
|---|
| 76420-713-01 | 76420071301 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-713-01) | 2024-04-11 | No | No | Historical |
| 76420-713-30 | 76420071330 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-713-30) | 2024-04-11 | No | No | Historical |
| 76420-713-60 | 76420071360 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-713-60) | 2024-04-11 | No | No | Historical |
| 76420-713-90 | 76420071390 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-713-90) | 2024-04-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| FAMOTIDINE | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2024-04-12 | HUMAN PRESCRIPTION DRUG LABEL | 1 |