Nizoral
- Product NDC
- 50580-895
- 11-digit product format
- 505800895
- Labeler code
- 50580
- Product ID
- 50580-895_490715fc-184d-4fcf-9e27-4209db5d18da
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- SHAMPOO
- Route
- TOPICAL
- Labeler
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Application
- NDA020310
- Marketing category
- NDA
- Marketing start
- 1999-04-01
- Marketing end
- 0000-00-00
- Substance
- KETOCONAZOLE
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50580-895-04 | 2021-09-24 | C162847 | 48780-1 | c7ccaba7-20ee-fd44-e053-dadaa90aa01b | 0ae873af-1307-4cfb-b508-988e08bd8499 |
| 50580-895-07 | 2021-09-24 | C162847 | 48780-1 | c7ccaba7-20ee-fd44-e053-dadaa90aa01b | 0ae873af-1307-4cfb-b508-988e08bd8499 |
| 50580-895-14 | 2021-09-24 | C162847 | 48780-1 | c7ccaba7-20ee-fd44-e053-dadaa90aa01b | 0ae873af-1307-4cfb-b508-988e08bd8499 |
| 50580-895-15 | 2021-09-24 | C162847 | 48780-1 | c7ccaba7-20ee-fd44-e053-dadaa90aa01b | 0ae873af-1307-4cfb-b508-988e08bd8499 |
| 50580-895-04 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-20ee-fd44-e053-dadaa90aa01b | 0ae873af-1307-4cfb-b508-988e08bd8499 |
| 50580-895-07 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-20ee-fd44-e053-dadaa90aa01b | 0ae873af-1307-4cfb-b508-988e08bd8499 |
| 50580-895-14 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-20ee-fd44-e053-dadaa90aa01b | 0ae873af-1307-4cfb-b508-988e08bd8499 |
| 50580-895-15 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-20ee-fd44-e053-dadaa90aa01b | 0ae873af-1307-4cfb-b508-988e08bd8499 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-895-04 | ML - Milliliter | 50580-895 | de28f2d0-5696-4fbe-89b1-5ba91cc062e9 | 1 | 2012-07-24 |
| 50580-895-07 | ML - Milliliter | 50580-895 | 0cd4993d-fb10-4ff7-9129-1e5d50d8d4e1 | 1 | 2012-07-24 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-895-04 | 50580089504 | 1 BOTTLE in 1 CARTON (50580-895-04) > 125 mL in 1 BOTTLE | 1 bottle | 1999-04-01 | 0000-00-00 | No | No | Current |
| 50580-895-07 | 50580089507 | 1 BOTTLE in 1 CARTON (50580-895-07) > 200 mL in 1 BOTTLE | 1 bottle | 1999-04-01 | 0000-00-00 | No | No | Current |
| 50580-895-14 | 50580089514 | 1 BOTTLE in 1 CARTON (50580-895-14) > 125 mL in 1 BOTTLE | 1 bottle | 1999-04-01 | 0000-00-00 | No | No | Current |
| 50580-895-15 | 50580089515 | 10 PACKET in 1 CARTON (50580-895-15) > 6 mL in 1 PACKET | 10 packet | 1999-04-01 | 0000-00-00 | No | No | Current |