Oxistat
- Product NDC
- 10337-359
- 11-digit product format
- 103370359
- Labeler code
- 10337
- Product ID
- 10337-359_c31b3c09-29fc-45ca-a742-3b5a9f553517
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxiconazole nitrate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- PharmaDerm a division of Fougera Pharmaceuticals Inc.
- Application
- NDA020209
- Marketing category
- NDA
- Marketing start
- 1992-09-30
- Marketing end
- 0000-00-00
- Substance
- OXICONAZOLE NITRATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC],Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10337-359-07 | 2020-09-11 | C162847 | 48780-1 | ab0e2407-30df-f274-e053-dbdaa90a6471 | b87a89d2-6e45-4eb8-be2c-7f55f34d61e5 |
| 10337-359-30 | 2020-09-11 | C162847 | 48780-1 | ab0e2407-30df-f274-e053-dbdaa90a6471 | b87a89d2-6e45-4eb8-be2c-7f55f34d61e5 |
| 10337-359-60 | 2020-09-11 | C162847 | 48780-1 | ab0e2407-30df-f274-e053-dbdaa90a6471 | b87a89d2-6e45-4eb8-be2c-7f55f34d61e5 |
| 10337-359-66 | 2020-09-11 | C162847 | 48780-1 | ab0e2407-30df-f274-e053-dbdaa90a6471 | b87a89d2-6e45-4eb8-be2c-7f55f34d61e5 |
| 10337-359-07 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-30df-f274-e053-dbdaa90a6471 | b87a89d2-6e45-4eb8-be2c-7f55f34d61e5 |
| 10337-359-30 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-30df-f274-e053-dbdaa90a6471 | b87a89d2-6e45-4eb8-be2c-7f55f34d61e5 |
| 10337-359-60 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-30df-f274-e053-dbdaa90a6471 | b87a89d2-6e45-4eb8-be2c-7f55f34d61e5 |
| 10337-359-66 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-30df-f274-e053-dbdaa90a6471 | b87a89d2-6e45-4eb8-be2c-7f55f34d61e5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10337-359-30 | ML - Milliliter | 10337-359 | bdfc33a1-fd8f-4edc-ab4b-599332e7e077 | 1 | 2013-02-13 |
| 10337-359-60 | ML - Milliliter | 10337-359 | b4d2e581-e57c-4449-860d-1e06ad4a749f | 1 | 2013-02-13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10337-359-07 | 10337035907 | 7 mL in 1 BOTTLE (10337-359-07) | 7 ml | 1992-09-30 | 0000-00-00 | No | No | Current |
| 10337-359-30 | 10337035930 | 1 BOTTLE in 1 CARTON (10337-359-30) > 30 mL in 1 BOTTLE | 1 bottle | 1992-09-30 | 0000-00-00 | No | No | Current |
| 10337-359-60 | 10337035960 | 1 BOTTLE in 1 CARTON (10337-359-60) > 60 mL in 1 BOTTLE | 1 bottle | 1992-09-30 | 0000-00-00 | No | No | Current |
| 10337-359-66 | 10337035966 | 6 BOTTLE in 1 CARTON (10337-359-66) > 7 mL in 1 BOTTLE | 6 bottle | 1992-09-30 | 0000-00-00 | No | No | Current |