FAMOTIDINE
- Product NDC
- 68788-8518
- 11-digit product format
- 687888518
- Labeler code
- 68788
- Product ID
- 68788-8518_a58e51a0-5e60-4a69-aaea-4b741826c372
- 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
- 2023-09-01
- 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
- 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 284245 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8518-3 | FAMOTIDINE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68788-8518-4 | FAMOTIDINE | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 4 |
| 68788-8518-6 | FAMOTIDINE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 68788-8518-9 | 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 |
|---|
| 68788-8518 | FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 4 package rows | 20250511_dbf94314-3a34-4f03-80b1-296559b7d6a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8518-3 | 68788851803 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8518-3) | 2023-09-01 | No | No | Historical |
| 68788-8518-4 | 68788851804 | 14 TABLET, FILM COATED in 1 BOTTLE (68788-8518-4) | 2023-09-01 | No | No | Historical |
| 68788-8518-6 | 68788851806 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8518-6) | 2023-09-01 | No | No | Historical |
| 68788-8518-9 | 68788851809 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8518-9) | 2023-09-01 | No | No | Historical |