Gentamicin Sulfate
- Product NDC
- 0409-1207
- 11-digit product format
- 004091207
- Labeler code
- 0409
- Product ID
- 0409-1207_317c0976-12f8-4263-bcb5-66583d1a1cae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GENTAMICIN SULFATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hospira, Inc.
- 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 |
|---|
| 0409-1207-03 | Gentamicin Sulfate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 22 |
| 0409-1207-13 | Gentamicin Sulfate | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GENTAMICIN SULFATE | ACTIVE INGREDIENT | 8X7386QRLV | GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| GENTAMICIN | ACTIVE MOIETY | T6Z9V48IKG | GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| EDETATE DISODIUM ANHYDROUS | INACTIVE INGREDIENT | 8NLQ36F6MM | GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| 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 |
|---|
| 0409-1207 | GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20241218_977180b3-a222-4282-d485-4a3217674305.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 |
|---|
| 0409-1207-03 | 00409120703 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1207-03) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-1207-13) | | 2005-08-29 | 0000-00-00 | No | No | Current |
| 0409-1207-13 | 00409120713 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |
| 0409-1207-25 | 00409120725 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1207-25) > 2 mL in 1 VIAL, SINGLE-DOSE (0409-1207-15) | | 2015-12-09 | 0000-00-00 | No | No | Current |