Famotidine
- Product NDC
- 64980-623
- 11-digit product format
- 649800623
- Labeler code
- 64980
- Product ID
- 64980-623_3f43a0a4-1606-4d45-95c0-46b73e504010
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA218181
- Marketing category
- ANDA
- Marketing start
- 2024-05-06
- 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 | 284245, 310273 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64980-623-01 | Famotidine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 64980-623-10 | Famotidine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 1 |
| 64980-623-50 | Famotidine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-623 | FAMOTIDINE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 3 package rows | 20240606_15b87f7f-1abf-4d8a-bdbe-03bea0021a68.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 64980-623-01 | 64980062301 | 100 TABLET, FILM COATED in 1 BOTTLE (64980-623-01) | 2024-05-06 | No | No | Current |
| 64980-623-10 | 64980062310 | 1000 TABLET, FILM COATED in 1 BOTTLE (64980-623-10) | 2024-05-06 | No | No | Current |
| 64980-623-50 | 64980062350 | 500 TABLET, FILM COATED in 1 BOTTLE (64980-623-50) | 2024-05-06 | No | No | Current |