Gentamicin Sulfate
- Product NDC
- 55154-2392
- 11-digit product format
- 551542392
- Labeler code
- 55154
- Product ID
- 55154-2392_77f135ab-2291-487d-a9e2-50818624fa1a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA062420
- Marketing category
- ANDA
- Marketing start
- 2005-08-29
- Substance
- GENTAMICIN SULFATE
- Active strength
- 40 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GENTAMICIN SULFATE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8X7386QRLV |
| Rxcui | 1870650 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-2392-5 | Gentamicin Sulfate | 5 in 1 BAG | INJECTION, SOLUTION | 5 | | 14 |
| 55154-2392-5 | Gentamicin Sulfate | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Gentamicin Sulfate | ACTIVE INGREDIENT | 8X7386QRLV | GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH] | 4 | |
| Gentamicin | ACTIVE MOIETY | T6Z9V48IKG | GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH] | 4 | |
| EDETATE DISODIUM ANHYDROUS | INACTIVE INGREDIENT | 8NLQ36F6MM | GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH] | 4 | |
| NITROGEN | INACTIVE INGREDIENT | N762921K75 | GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH] | 4 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH] | 4 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH] | 4 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH] | 4 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-2392 | GENTAMICIN SULFATE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240910_5113bfad-42ca-4bb8-9343-0b08c6cd03f0.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 |
|---|
| 55154-2392-5 | 55154239205 | 5 VIAL, SINGLE-DOSE in 1 BAG (55154-2392-5) / 2 mL in 1 VIAL, SINGLE-DOSE | 2005-08-29 | 0000-00-00 | No | No | Current |