Gentamicin Sulfate
- Product NDC
- 61919-918
- 11-digit product format
- 619190918
- Labeler code
- 61919
- Product ID
- 61919-918_b3db8815-3e22-5441-e053-2a95a90a5cc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- DIRECT RX
- Application
- ANDA064163
- Marketing category
- ANDA
- Marketing start
- 2019-03-19
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 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 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| 48b05f5d-d2fc-45ab-76e8-3cb5bd44890d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-918-05 | Gentamicin Sulfate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-918-05 | ML - Milliliter | 61919-918 | d782301e-ac21-42c6-bdb2-cbfa838c2edc | 1 | 2019-04-11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| 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#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310467 | gentamicin sulfate 0.3 % Ophthalmic Solution | PSN | 51a411a0-2671-4c1c-bf25-e29b32efed0c | 8 |
| 310467 | gentamicin 3 MG/ML Ophthalmic Solution | SCD | 51a411a0-2671-4c1c-bf25-e29b32efed0c | 8 |
| 310467 | gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution | SY | 51a411a0-2671-4c1c-bf25-e29b32efed0c | 8 |
| 310467 | gentamicin sulfate 3 MG/ML Ophthalmic Solution | SY | 51a411a0-2671-4c1c-bf25-e29b32efed0c | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-918-05 | 61919091805 | 5 mL in 1 BOTTLE, DROPPER (61919-918-05) | 5 ml | 2019-03-19 | 0000-00-00 | No | No | Current |