Famotidine
- Product NDC
- 57896-319
- 11-digit product format
- 578960319
- Labeler code
- 57896
- Product ID
- 57896-319_288ab319-e163-0a6b-e063-6394a90a9205
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Geri-Care Pharmaceutical Corp
- Application
- ANDA215822
- Marketing category
- ANDA
- Marketing start
- 2024-04-01
- 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 |
|---|
| 57896-319-01 | Famotidine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
| 57896-319-01 | Famotidine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57896-319 | FAMOTIDINE TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] | 1 | Current NDC, 2 package rows | 20241208_288a8f87-e84a-a77a-e063-6294a90a86db.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57896-319-01 | 57896031901 | 1 BOTTLE in 1 CARTON (57896-319-01) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-04-01 | No | No | Historical |