Famotidine
- Product NDC
- 70954-316
- 11-digit product format
- 709540316
- Labeler code
- 70954
- Product ID
- 70954-316_5dd78321-82a9-48a6-9974-d8d27e9785cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA215043
- Marketing category
- ANDA
- Marketing start
- 2021-04-20
- 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 |
|---|
| 70954-316-10 | Famotidine | 50 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-316 | FAMOTIDINE POWDER, FOR SUSPENSION [ANI PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231003_8e41e259-b161-4f11-a6f7-14e6b60885b8.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 |
|---|
| 70954-316-10 | 70954031610 | 50 mL in 1 BOTTLE (70954-316-10) | 50 ml | 2021-04-20 | 0000-00-00 | No | No | Current |