Gentamicin Sulfate Opth Solution
- Product NDC
- 72189-359
- 11-digit product format
- 721890359
- Labeler code
- 72189
- Product ID
- 72189-359_4d3a9fbe-9f7c-e1a0-e063-6294a90a7857
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate Opth Solution
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Direct_Rx
- Application
- ANDA064048
- Marketing category
- ANDA
- Marketing start
- 2022-06-17
- Substance
- GENTAMICIN SULFATE
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gentamicin Sulfate Opth Solution
- Listing expiration
- 2027-12-31
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 |
|---|
| 72189-359-05 | Gentamicin Sulfate Opth Solution | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-359 | GENTAMICIN SULFATE OPTH SOLUTION SOLUTION/ DROPS [DIRECT_RX] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250123_e1a5bc32-f9a0-6b33-e053-2995a90ab9ac.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 |
|---|
| 72189-359-05 | 72189035905 | 5 mL in 1 BOTTLE, DROPPER (72189-359-05) | 5 ml | 2022-06-17 | 0000-00-00 | No | No | Current |