FAMOTIDINE
- Product NDC
- 80005-119
- 11-digit product format
- 800050119
- Labeler code
- 80005
- Product ID
- 80005-119_7753e6db-5fe8-4b35-8817-c50abda35144
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FAMOTIDINE
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Carnegie Pharmaceuticals LLC
- Application
- ANDA217137
- Marketing category
- ANDA
- Marketing start
- 2023-08-10
- Substance
- FAMOTIDINE
- Active strength
- 40 mg/5mL
- 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 | 40 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 310274 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80005-119-16 | FAMOTIDINE | 50 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 50 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80005-119 | FAMOTIDINE POWDER, FOR SUSPENSION [CARNEGIE PHARMACEUTICALS LLC] | 6 | Current NDC, 1 package rows | 20230810_45df5fae-b28a-4b48-95ef-96e4faad883f.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 |
|---|
| 80005-119-16 | 80005011916 | 50 mL in 1 BOTTLE (80005-119-16) | 50 ml | 2023-08-10 | No | No | Current |