Famotidine
- Product NDC
- 71821-010
- 11-digit product format
- 718210010
- Labeler code
- 71821
- Product ID
- 71821-010_0fc43ab9-0e23-258f-e063-6394a90a0c40
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- VKT Pharma Private Limited
- Application
- ANDA215822
- Marketing category
- ANDA
- Marketing start
- 2022-01-28
- 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 |
|---|
| 71821-010-12 | Famotidine | 144230 in 1 BAG | TABLET, FILM COATED | 144230 | | 4 |
| 71821-010-13 | Famotidine | 144230 in 1 BAG | TABLET, FILM COATED | 144230 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71821-010 | FAMOTIDINE TABLET, FILM COATED [VKT PHARMA PRIVATE LIMITED] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240126_4e5db906-992f-476b-9d97-63a4c582bbdc.zip |
| 71821-010 | FAMOTIDINE TABLET, FILM COATED [VKT PHARMA PRIVATE LIMITED] | 1 | Current NDC, Legacy NDC, 1 package rows | 20240524_1c2cfb3c-eaa0-403f-9589-d706afc06f51.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 |
|---|
| 71821-010-12 | 71821001012 | 144230 TABLET, FILM COATED in 1 BAG (71821-010-12) | 2022-09-07 | 0000-00-00 | No | No | Current |
| 71821-010-13 | 71821001013 | 144230 TABLET, FILM COATED in 1 BAG (71821-010-13) | 2024-05-23 | | No | No | Historical |