Famotidine
- Product NDC
- 67457-448
- 11-digit product format
- 674570448
- Labeler code
- 67457
- Product ID
- 67457-448_04ba0afe-908e-4948-a757-44b59de09ae3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA078641
- Marketing category
- ANDA
- Marketing start
- 2008-06-26
- Substance
- FAMOTIDINE
- Active strength
- 10 mg/mL
- 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 204441, 1743833 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-448-00 | Famotidine | 4 mL in 1 VIAL | INJECTION | 4 | | 6 |
| 67457-448-43 | Famotidine | 10 in 1 CARTON | INJECTION | 10 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-448 | FAMOTIDINE INJECTION [MYLAN INSTITUTIONAL LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20201219_e3b13e23-122b-4bd4-95cf-b5a14b7afc05.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 |
|---|
| 67457-448-00 | 67457044800 | 4 mL in 1 VIAL | 4 ml | | | | | Historical |
| 67457-448-43 | 67457044843 | 10 VIAL in 1 CARTON (67457-448-43) / 4 mL in 1 VIAL (67457-448-00) | 10 vial | 2008-06-26 | 0000-00-00 | No | No | Current |