Gentamicin Sulfate
- Product NDC
- 17478-283
- 11-digit product format
- 174780283
- Labeler code
- 17478
- Product ID
- 17478-283_b09bb7e8-6fdf-42a3-b56b-07676e04d387
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA064163
- Marketing category
- ANDA
- Marketing start
- 2006-12-13
- 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 |
|---|
| 17478-283-10 | Gentamicin Sulfate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 5 |
| 17478-283-10 | Gentamicin Sulfate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Gentamicin Sulfate | ACTIVE INGREDIENT | 8X7386QRLV | GENTAMICIN SULFATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Gentamicin | ACTIVE MOIETY | T6Z9V48IKG | GENTAMICIN SULFATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Benzalkonium Chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | GENTAMICIN SULFATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | GENTAMICIN SULFATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Sodium Phosphate, Dibasic, Anhydrous | INACTIVE INGREDIENT | 22ADO53M6F | GENTAMICIN SULFATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Sodium Phosphate, Monobasic | INACTIVE INGREDIENT | 3980JIH2SW | GENTAMICIN SULFATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| gentamicin sulfate | ACTIVE INGREDIENT | 8X7386QRLV | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| GENTAMICIN | ACTIVE MOIETY | T6Z9V48IKG | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-283 | GENTAMICIN SULFATE SOLUTION/ DROPS [AKORN] | 5 | Legacy NDC, 2 package rows | 20220129_877ab1fd-6c0e-42f6-9522-f5efaa96018d.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 |
|---|
| 17478-283-10 | 17478028310 | 1 BOTTLE, DROPPER in 1 CARTON (17478-283-10) > 5 mL in 1 BOTTLE, DROPPER | 2006-12-13 | 0000-00-00 | No | No | Current |