FAMOTIDINE
- Product NDC
- 43602-602
- 11-digit product format
- 436020602
- Labeler code
- 43602
- Product ID
- 43602-602_a2adad08-283e-4617-b3db-1eade7f5b296
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascent Pharmaceuticals, Inc.
- Application
- ANDA216030
- Marketing category
- ANDA
- Marketing start
- 2021-11-03
- 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 | 199047, 310273 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43602-602-03 | FAMOTIDINE | 1 in 1 CARTON | TABLET | 1 | | 3 |
| 43602-602-03 | FAMOTIDINE | 300 in 1 BOTTLE | TABLET | 300 | | 3 |
| 43602-602-30 | FAMOTIDINE | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 43602-602-30 | FAMOTIDINE | 1 in 1 CARTON | TABLET | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43602-602 | FAMOTIDINE TABLET [ASCENT PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20220218_b481dd30-7d64-43ec-85d4-2289db62cad7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43602-602-03 | 43602060203 | 1 BOTTLE in 1 CARTON (43602-602-03) / 300 TABLET in 1 BOTTLE | 1 bottle | 2021-11-03 | 0000-00-00 | No | No | Current |
| 43602-602-30 | 43602060230 | 1 BOTTLE in 1 CARTON (43602-602-30) / 30 TABLET in 1 BOTTLE | 1 bottle | 2021-11-03 | 0000-00-00 | No | No | Current |