Gentamicin Sulfate in Sodium Chloride
- Product NDC
- 0338-0509
- 11-digit product format
- 003380509
- Labeler code
- 0338
- Product ID
- 0338-0509_aacff3ac-5df9-4872-b074-78930c9c9b79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- ANDA062373
- Marketing category
- ANDA
- Marketing start
- 1982-09-07
- Substance
- GENTAMICIN SULFATE
- Active strength
- 80 mg/50mL
- 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 in Sodium Chloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GENTAMICIN SULFATE | 80 mg/50mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 8X7386QRLV |
| Rxcui | 197736, 242816, 310473, 310477, 1870631, 1870633 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3b7b3a7a-635f-32a3-0c6c-7ad028e3de91 | Product name | 2 | 20250107 |
| 43025f0d-698c-68da-cec9-ea4261a7ef7a | Product name | 2 | 20250107 |
| d3946667-8212-d1f2-67e1-5643a329bb56 | Product name | 2 | 20200403 |
| 4ce5dce5-e8a7-e4f6-0059-b527e4307477 | Product name | 2 | 20190501 |
| 48b05f5d-d2fc-45ab-76e8-3cb5bd44890d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0338-0509-41 | Gentamicin Sulfate in Sodium Chloride | 50 mL in 1 BAG | INJECTION, SOLUTION | 50 | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-0509-41 | ML - Milliliter | 0338-0509 | 05f9f25e-c631-4365-b003-011cb866fe91 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GENTAMICIN SULFATE | ACTIVE INGREDIENT | 8X7386QRLV | GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 7 | |
| GENTAMICIN | ACTIVE MOIETY | T6Z9V48IKG | GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 7 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 7 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 7 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0338-0509 | GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 19 | Current NDC, Legacy NDC, 1 package rows | 20250214_449c9a41-d61e-49fd-b5e3-d76f74b92acf.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 242816 | gentamicin sulfate 100 MG in 100 ML Injection | PSN | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 197736 | gentamicin sulfate 100 MG in 50 ML Injection | PSN | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 1870631 | gentamicin sulfate 120 MG in 100 ML Injection | PSN | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 1870633 | gentamicin sulfate 60 MG in 50 ML Injection | PSN | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 310473 | gentamicin sulfate 80 MG in 100 ML Injection | PSN | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 310477 | gentamicin sulfate 80 MG in 50 ML Injection | PSN | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 310473 | 100 ML gentamicin 0.8 MG/ML Injection | SCD | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 242816 | 100 ML gentamicin 1 MG/ML Injection | SCD | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 1870631 | 100 ML gentamicin 1.2 MG/ML Injection | SCD | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 1870633 | 50 ML gentamicin 1.2 MG/ML Injection | SCD | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 310477 | 50 ML gentamicin 1.6 MG/ML Injection | SCD | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 197736 | 50 ML gentamicin 2 MG/ML Injection | SCD | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 242816 | gentamicin (as gentamicin sulfate) 100 MG per 100 ML Injection | SY | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 197736 | gentamicin (as gentamicin sulfate) 100 MG per 50 ML Injection | SY | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 1870631 | gentamicin (as gentamicin sulfate) 120 MG per 100 ML Injection | SY | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 1870633 | gentamicin (as gentamicin sulfate) 60 MG per 50 ML Injection | SY | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 310473 | gentamicin (as gentamicin sulfate) 80 MG per 100 ML Injection | SY | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
| 310477 | gentamicin (as gentamicin sulfate) 80 MG per 50 ML Injection | SY | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 20 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0338-0509-41 | 00338050941 | 50 mL in 1 BAG (0338-0509-41) | 50 ml | 1982-09-07 | 0000-00-00 | No | No | Current |