FAMOTIDINE
- Product NDC
- 72789-453
- 11-digit product format
- 727890453
- Labeler code
- 72789
- Product ID
- 72789-453_324937c3-c52f-bc79-e063-6294a90acc8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FAMOTIDINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FAMOTIDINE
- Listing expiration
- 2026-12-31
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 |
|---|
| 72789-453-30 | FAMOTIDINE | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-453 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | Current NDC, 1 package rows | 20250410_a0f38398-4d34-4ecc-8a6a-37732adaaad3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-453-30 | 72789045330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-453-30) | 2024-11-14 | No | No | Current |