Fluconazole
- Product NDC
- 63187-613
- 11-digit product format
- 631870613
- Labeler code
- 63187
- Product ID
- 63187-613_4a5d7cd0-63f5-4f16-b335-ad27a3c0b519
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA076077
- Marketing category
- ANDA
- Marketing start
- 2004-07-29
- Marketing end
- 0000-00-00
- Substance
- FLUCONAZOLE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-613 | FLUCONAZOLE TABLET [PROFICIENT RX LP] | 3 | Legacy NDC | 20191121_b19e48e5-97c6-4b38-8721-8747b9c1a36a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-613-01 | 63187061301 | 1 TABLET in 1 BLISTER PACK (63187-613-01) | 1 tablet | 2018-12-01 | 0000-00-00 | No | No | Current |