Famotidine
- Product NDC
- 68788-4021
- 11-digit product format
- 687884021
- Labeler code
- 68788
- Product ID
- 68788-4021_6edbd842-cf86-48a5-bc22-967620a2b5cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA217400
- Marketing category
- ANDA
- Marketing start
- 2025-09-05
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Famotidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FAMOTIDINE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 310273 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-4021-3 | Famotidine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 68788-4021-4 | Famotidine | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 1 |
| 68788-4021-6 | Famotidine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 68788-4021-9 | Famotidine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4021-3 | 68788402103 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4021-3) | 2025-09-05 | No | No | Historical |
| 68788-4021-4 | 68788402104 | 14 TABLET, FILM COATED in 1 BOTTLE (68788-4021-4) | 2025-09-05 | No | No | Historical |
| 68788-4021-6 | 68788402106 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4021-6) | 2025-09-05 | No | No | Historical |
| 68788-4021-9 | 68788402109 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-4021-9) | 2025-09-05 | No | No | Historical |