Gentamicin Sulfate
- Product NDC
- 76420-254
- 11-digit product format
- 764200254
- Labeler code
- 76420
- Product ID
- 76420-254_e425b6aa-1415-785f-e053-2a95a90a4350
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA064048
- Marketing category
- ANDA
- Marketing start
- 1994-05-11
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-254-05 | Gentamicin Sulfate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 76420-254-05 | Gentamicin Sulfate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-254 | GENTAMICIN SULFATE SOLUTION/ DROPS [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220722_b59e49e0-640b-43c3-ad07-711d1bb154e9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-254-05 | 76420025405 | 1 BOTTLE, DROPPER in 1 CARTON (76420-254-05) / 5 mL in 1 BOTTLE, DROPPER | 2022-07-19 | 0000-00-00 | No | No | Current |