Famotidine
- Product NDC
- 68788-8889
- 11-digit product format
- 687888889
- Labeler code
- 68788
- Product ID
- 68788-8889_5ed77259-5dd9-4634-a073-346693488c4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA075718
- Marketing category
- ANDA
- Marketing start
- 2025-09-23
- Substance
- FAMOTIDINE
- Active strength
- 20 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
- 68788-8889_5ed77259-5dd9-4634-a073-346693488c4f
- SPL ID
- 5ed77259-5dd9-4634-a073-346693488c4f
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Famotidine
- Generic name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2025-09-23
- Marketing category
- ANDA
- Application number
- ANDA075718
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA]; Histamine-2 Receptor Antagonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| FAMOTIDINE | 20 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 310273 |
| Spl Set Id | 5ed77259-5dd9-4634-a073-346693488c4f |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 68788-8889-1 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8889-1) | 2025-09-23 | No |
| 68788-8889-3 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8889-3) | 2025-09-23 | No |
| 68788-8889-6 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8889-6) | 2025-09-23 | No |
| 68788-8889-9 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8889-9) | 2025-09-23 | No |
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 |
|---|
| 68788-8889-1 | 68788888901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8889-1) | 2025-09-23 | No | No | Historical |
| 68788-8889-3 | 68788888903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8889-3) | 2025-09-23 | No | No | Historical |
| 68788-8889-6 | 68788888906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8889-6) | 2025-09-23 | No | No | Historical |
| 68788-8889-9 | 68788888909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8889-9) | 2025-09-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Famotidine | Preferred Pharmaceuticals Inc. | 2025-09-23 | HUMAN PRESCRIPTION DRUG LABEL | 1 |