Ketoconazole
- Product NDC
- 0713-0671
- 11-digit product format
- 007130671
- Labeler code
- 0713
- Product ID
- 0713-0671_6f17892d-bcf0-4173-9090-67c5a9bedcfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- G&W Laboratories, Inc.
- Application
- ANDA075581
- Marketing category
- ANDA
- Marketing start
- 2015-06-15
- Marketing end
- 0000-00-00
- Substance
- KETOCONAZOLE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0713-0671-15 | 2021-08-20 | C162847 | 48780-1 | 9d75b9d0-f652-f424-e053-dadaa90a57ce | 5f0c9d23-6bac-42e9-aec4-cacfec800511 |
| 0713-0671-31 | 2021-08-20 | C162847 | 48780-1 | 9d75b9d0-f652-f424-e053-dadaa90a57ce | 5f0c9d23-6bac-42e9-aec4-cacfec800511 |
| 0713-0671-60 | 2021-08-20 | C162847 | 48780-1 | 9d75b9d0-f652-f424-e053-dadaa90a57ce | 5f0c9d23-6bac-42e9-aec4-cacfec800511 |
| 0713-0671-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f652-f424-e053-dadaa90a57ce | 5f0c9d23-6bac-42e9-aec4-cacfec800511 |
| 0713-0671-31 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f652-f424-e053-dadaa90a57ce | 5f0c9d23-6bac-42e9-aec4-cacfec800511 |
| 0713-0671-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f652-f424-e053-dadaa90a57ce | 5f0c9d23-6bac-42e9-aec4-cacfec800511 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0713-0671-15 | GM - Gram | 0713-0671 | 7e1d46b4-20d7-420c-b9e4-cdb30fbd60b8 | 1 | 2015-07-20 |
| 0713-0671-31 | GM - Gram | 0713-0671 | 908822ca-b6e1-4c63-b4c6-9b0c039c4424 | 1 | 2015-07-20 |
| 0713-0671-60 | GM - Gram | 0713-0671 | fa69f695-511d-41f0-9a11-ec377bf05a1a | 1 | 2015-07-20 |