GENTAMICIN SULFATE
- Product NDC
- 60758-188
- 11-digit product format
- 607580188
- Labeler code
- 60758
- Product ID
- 60758-188_16002455-98e2-4456-9112-525f5a0f71b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gentamicin sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Pacific Pharma, Inc.
- Application
- ANDA062452
- Marketing category
- ANDA
- Marketing start
- 1998-01-05
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| gentamicin sulfate | ACTIVE INGREDIENT | 8X7386QRLV | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 4 | |
| gentamicin | ACTIVE MOIETY | T6Z9V48IKG | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 4 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 4 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 4 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 4 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 4 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 4 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 4 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 4 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 4 | |
| GENTAMICIN SULFATE | ACTIVE INGREDIENT | 8X7386QRLV | GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| gentamicin sulfate | ACTIVE INGREDIENT | 8X7386QRLV | GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| gentamicin sulfate | ACTIVE INGREDIENT | 8X7386QRLV | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| GENTAMICIN | ACTIVE MOIETY | T6Z9V48IKG | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| GENTAMICIN | ACTIVE MOIETY | T6Z9V48IKG | GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| gentamicin | ACTIVE MOIETY | T6Z9V48IKG | GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP] | 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 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60758-188 | GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 8 | Legacy NDC | 20240921_0bc9fa00-1755-4989-a222-a038e970371f.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 |
|---|
| 60758-188-05 | 60758018805 | 1 BOTTLE, DROPPER in 1 CARTON (60758-188-05) > 5 mL in 1 BOTTLE, DROPPER | 1998-01-05 | 0000-00-00 | No | No | Current |