Gentamicin
- Product NDC
- 0404-9866
- 11-digit product format
- 004049866
- Labeler code
- 0404
- Product ID
- 0404-9866_65ca54d7-de8c-4c5f-b47e-393f24de2af9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc
- Application
- ANDA062366
- Marketing category
- ANDA
- Marketing start
- 2022-01-10
- Substance
- GENTAMICIN SULFATE
- Active strength
- 40 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GENTAMICIN SULFATE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8X7386QRLV |
| Rxcui | 313996 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9866-20 | Gentamicin | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 6 |
| 0404-9866-20 | Gentamicin | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9866 | GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [HENRY SCHEIN, INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240901_84f6eb1c-a287-489a-8c3e-aa5954cf1992.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 |
|---|
| 0404-9866-20 | 00404986620 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9866-20) / 20 mL in 1 VIAL, MULTI-DOSE | 2022-01-10 | 0000-00-00 | No | No | Current |