FAMOTIDINE
- Product NDC
- 68788-8485
- 11-digit product format
- 687888485
- Labeler code
- 68788
- Product ID
- 68788-8485_70b50c77-9a69-4898-bfe2-813872788a4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FAMOTIDINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA215630
- Marketing category
- ANDA
- Marketing start
- 2023-07-18
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FAMOTIDINE
- Listing expiration
- 2027-12-31
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 |
|---|
| 68788-8485-3 | FAMOTIDINE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68788-8485-4 | FAMOTIDINE | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 4 |
| 68788-8485-6 | FAMOTIDINE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 68788-8485-9 | FAMOTIDINE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8485 | FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 4 package rows | 20250510_b445a613-eaa8-45e8-be1f-5848bfd1dd36.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8485-3 | 68788848503 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8485-3) | 2023-07-18 | No | No | Historical |
| 68788-8485-4 | 68788848504 | 14 TABLET, FILM COATED in 1 BOTTLE (68788-8485-4) | 2023-07-18 | No | No | Historical |
| 68788-8485-6 | 68788848506 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8485-6) | 2023-07-18 | No | No | Historical |
| 68788-8485-9 | 68788848509 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8485-9) | 2023-07-18 | No | No | Historical |