FAMOTIDINE
- Product NDC
- 68382-444
- 11-digit product format
- 683820444
- Labeler code
- 68382
- Product ID
- 68382-444_707e6805-7f07-43d1-b65b-4afbb9e9e95e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- famotidine
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA091020
- Marketing category
- ANDA
- Marketing start
- 2021-04-22
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-444-05 | FAMOTIDINE | 50 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 50 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FAMOTIDINE | ACTIVE INGREDIENT | 5QZO15J2Z8 | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC] | 1 | |
| FAMOTIDINE | ACTIVE MOIETY | 5QZO15J2Z8 | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC] | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC] | 1 | |
| METHYLPARABEN SODIUM | INACTIVE INGREDIENT | CR6K9C2NHK | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC] | 1 | |
| PROPYLPARABEN SODIUM | INACTIVE INGREDIENT | 625NNB0G9N | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-444 | FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20221213_a8010e10-68fd-455f-968f-d62a1c3e0ffd.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 |
|---|
| 68382-444-05 | 68382044405 | 50 mL in 1 BOTTLE, PLASTIC (68382-444-05) | 50 ml | 2021-04-22 | 0000-00-00 | No | No | Current |