terbinafine hydrochloride
- Product NDC
- 16714-501
- 11-digit product format
- 167140501
- Labeler code
- 16714
- Product ID
- 16714-501_a3e3e0c9-6f28-4812-a9b9-4c2a93c29dbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- terbinafine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA078163
- Marketing category
- ANDA
- Marketing start
- 2009-09-15
- Marketing end
- 2021-09-30
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine [CS],Allylamine Antifungal [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-501-01 | 16714050101 | 30 TABLET in 1 BOTTLE, PLASTIC (16714-501-01) | 30 tablet | 2009-09-15 | 2021-09-30 | No | No | Current |
| 16714-501-02 | 16714050102 | 100 TABLET in 1 BOTTLE, PLASTIC (16714-501-02) | 100 tablet | 2009-09-15 | 2021-09-30 | No | No | Current |