Gentamicin Sulfate
- Product NDC
- 68071-4775
- 11-digit product format
- 680714775
- Labeler code
- 68071
- Product ID
- 68071-4775_1adbfbb6-92b8-3288-e063-6394a90a6f29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA062196
- Marketing category
- ANDA
- Marketing start
- 1996-04-05
- Substance
- GENTAMICIN SULFATE
- Active strength
- 3 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 Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GENTAMICIN SULFATE | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8X7386QRLV |
| Rxcui | 310467 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4775-5 | Gentamicin Sulfate | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4775 | GENTAMICIN SULFATE SOLUTION [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240616_82595309-304e-a221-e053-2991aa0ac0a9.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 |
|---|
| 68071-4775-5 | 68071477505 | 5 mL in 1 BOTTLE (68071-4775-5) | 5 ml | 2019-02-20 | 0000-00-00 | No | No | Current |