Famotidine
- Product NDC
- 54257-802
- 11-digit product format
- 542570802
- Labeler code
- 54257
- Product ID
- 54257-802_54c5dd3f-7261-47e2-adfc-23ef9955eb39
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Magno-Humphries, Inc.
- Application
- ANDA206531
- Marketing category
- ANDA
- Marketing start
- 2016-04-26
- 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 |
|---|
| 54257-802-02 | Famotidine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54257-802 | FAMOTIDINE TABLET, FILM COATED [MAGNO-HUMPHRIES, INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250507_f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54257-802-02 | 54257080202 | 100 TABLET, FILM COATED in 1 BOTTLE (54257-802-02) | 2016-04-26 | 0000-00-00 | No | No | Current |