GENTAMICIN
- Product NDC
- 51662-1508
- 11-digit product format
- 516621508
- Labeler code
- 51662
- Product ID
- 51662-1508_1032caaf-e8c2-e3cc-e063-6294a90a47f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GENTAMICIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA062366
- Marketing category
- ANDA
- Marketing start
- 2021-05-10
- Substance
- GENTAMICIN SULFATE
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GENTAMICIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GENTAMICIN SULFATE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8X7386QRLV |
| Rxcui | 313996 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1508-2 | GENTAMICIN | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | | 3 |
| 51662-1508-2 | GENTAMICIN | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 3 |
| 51662-1508-3 | GENTAMICIN | 25 in 1 BOX | INJECTION, SOLUTION | 25 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1508 | GENTAMICIN INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 3 | Current NDC, Legacy NDC, 3 package rows | 20240131_c1ff0cdc-ac5d-30ca-e053-2a95a90a5066.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 |
|---|
| 51662-1508-2 | 51662150802 | 20 mL in 1 VIAL | 20 ml | | | | | Historical |
| 51662-1508-3 | 51662150803 | 25 POUCH in 1 BOX (51662-1508-3) / 1 VIAL in 1 POUCH (51662-1508-2) / 20 mL in 1 VIAL | 25 pouch | 2021-05-10 | 0000-00-00 | No | No | Current |