FAMOTIDINE
- Product NDC
- 51662-1375
- 11-digit product format
- 516621375
- Labeler code
- 51662
- Product ID
- 51662-1375_e9fd11b6-5cbd-ba83-e053-2a95a90a42af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FAMOTIDINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA075813
- Marketing category
- ANDA
- Marketing start
- 2019-12-09
- 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 | 1743833 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1375-1 | FAMOTIDINE | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 3 |
| 51662-1375-2 | FAMOTIDINE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 3 |
| 51662-1375-2 | FAMOTIDINE | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1375 | FAMOTIDINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 3 | Current NDC, Legacy NDC, 3 package rows | 20221002_9948991d-9405-c7c8-e053-2995a90a60ca.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 |
|---|
| 51662-1375-1 | 51662137501 | 2 mL in 1 VIAL, SINGLE-DOSE (51662-1375-1) | 2 ml | 2019-12-09 | 0000-00-00 | No | No | Current |
| 51662-1375-2 | 51662137502 | 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1375-2) / 2 mL in 1 VIAL, SINGLE-DOSE | | 2022-10-01 | 0000-00-00 | No | No | Current |