GENTAMICIN SULFATE
- Product NDC
- 53002-9292
- 11-digit product format
- 530029292
- Labeler code
- 53002
- Product ID
- 53002-9292_08b4b0d2-356a-4604-aafa-926aa46bc675
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gentamicin sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA062452
- Marketing category
- ANDA
- Marketing start
- 1998-01-05
- Marketing end
- 0000-00-00
- Substance
- GENTAMICIN SULFATE
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 53002-9292-1 | 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 |
|---|
| 53002-9292 | GENTAMICIN SULFATE SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 1 package rows | 20220331_62c5c569-ae40-4ad2-81d9-7fe44c0ae18f.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 |
|---|
| 53002-9292-1 | 53002929201 | 5 mL in 1 BOTTLE, DROPPER (53002-9292-1) | 5 ml | 2022-01-01 | 0000-00-00 | No | No | Current |