Gentamicin
- Product NDC
- 0143-9129
- 11-digit product format
- 001439129
- Labeler code
- 0143
- Product ID
- 0143-9129_9908273d-c700-4036-82fe-312f25a8aacd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA062251
- Marketing category
- ANDA
- Marketing start
- 2022-02-15
- 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 |
|---|
| 0143-9129-01 | Gentamicin | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | | 2 |
| 0143-9129-10 | Gentamicin | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9129 | GENTAMICIN INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230908_51fffac8-fb6e-4f7f-b2de-440252781a42.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 |
|---|
| 0143-9129-01 | 00143912901 | 20 mL in 1 VIAL | 20 ml | | | | | Historical |
| 0143-9129-10 | 00143912910 | 10 VIAL in 1 CARTON (0143-9129-10) / 20 mL in 1 VIAL (0143-9129-01) | 10 vial | 2022-02-15 | 0000-00-00 | No | No | Current |