Famotidine
- Product NDC
- 70000-0048
- 11-digit product format
- 700000048
- Labeler code
- 70000
- Product ID
- 70000-0048_7718b199-6ce8-41c1-90fe-533d5a6d26cc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- LEADER/ CARDINAL HEALTH 110, INC.
- Application
- ANDA206531
- Marketing category
- ANDA
- Marketing start
- 2020-04-04
- Substance
- FAMOTIDINE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 199047 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0048-1 | Famotidine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 7 |
| 70000-0048-1 | Famotidine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0048 | FAMOTIDINE TABLET, FILM COATED [LEADER/ CARDINAL HEALTH 110, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250417_cdd509c4-331b-4aee-935c-dfc44d5943ed.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 |
|---|
| 70000-0048-1 | 70000004801 | 1 BOTTLE in 1 CARTON (70000-0048-1) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2020-04-04 | 0000-00-00 | No | No | Current |