Gentamicin sulfate
- Product NDC
- 0168-0078
- 11-digit product format
- 001680078
- Labeler code
- 0168
- Product ID
- 0168-0078_c6dd33a2-904b-4015-8477-5018db198fdc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA062533
- Marketing category
- ANDA
- Marketing start
- 2010-03-17
- Marketing end
- 0000-00-00
- Substance
- GENTAMICIN
- Active strength
- 1 mg/g
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0168-0078-15 | 2024-07-05 | C162847 | 48780-1 | 9d75b9d0-fa36-f424-e053-dadaa90a57ce | f986fa2a-e667-452f-be4c-bad8588af525 |
| 0168-0078-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fa36-f424-e053-dadaa90a57ce | f986fa2a-e667-452f-be4c-bad8588af525 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GENTAMICIN SULFATE | ACTIVE INGREDIENT | 8X7386QRLV | GENTAMICIN SULFATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| GENTAMICIN | ACTIVE MOIETY | T6Z9V48IKG | GENTAMICIN SULFATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | GENTAMICIN SULFATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | GENTAMICIN SULFATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | GENTAMICIN SULFATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310465 | gentamicin sulfate 0.1 % Topical Ointment | PSN | 78d87bc5-be86-4429-8ca3-e0a883108f9b | 2 |
| 310465 | gentamicin 0.001 MG/MG Topical Ointment | SCD | 78d87bc5-be86-4429-8ca3-e0a883108f9b | 2 |
| 310465 | gentamicin (as gentamicin sulfate) 0.1 % Topical Ointment | SY | 78d87bc5-be86-4429-8ca3-e0a883108f9b | 2 |
| 310465 | gentamicin sulfate 0.001 MG/MG Topical Ointment | SY | 78d87bc5-be86-4429-8ca3-e0a883108f9b | 2 |