famotidine
- Product NDC
- 68475-400
- 11-digit product format
- 684750400
- Labeler code
- 68475
- Product ID
- 68475-400_12419fdc-7a4c-4762-806c-0d56b478ef9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- famotidine
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Navinta LLC
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68475-400-01 | famotidine | 50 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 50 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68475-400 | FAMOTIDINE POWDER, FOR SUSPENSION [NAVINTA LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20220930_0f34a3be-7554-4040-b808-5ba8bf064abc.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 |
|---|
| 68475-400-01 | 68475040001 | 50 mL in 1 BOTTLE, PLASTIC (68475-400-01) | 50 ml | 2021-04-22 | 0000-00-00 | No | No | Current |