Terbinafine Hydrochloride
- Product NDC
- 43063-906
- 11-digit product format
- 430630906
- Labeler code
- 43063
- Product ID
- 43063-906_415d8510-666a-823c-e063-6394a90af490
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077714
- Marketing category
- ANDA
- Marketing start
- 2010-12-27
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine Antifungal [EPC], Allylamine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Terbinafine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERBINAFINE HYDROCHLORIDE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 012C11ZU6G |
| Rxcui | 313222 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-906-20 | Terbinafine Hydrochloride | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 20 |
| 43063-906-42 | Terbinafine Hydrochloride | 42 in 1 BOTTLE, PLASTIC | TABLET | 42 | | 20 |
| 43063-906-90 | Terbinafine Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-906 | TERBINAFINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 19 | Current NDC, Legacy NDC, 3 package rows | 20240704_2df111dc-ecac-4161-9e22-38436eb37c1f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-906-20 | 43063090620 | 20 TABLET in 1 BOTTLE, PLASTIC (43063-906-20) | 20 tablet | 2019-02-24 | 0000-00-00 | No | No | Current |
| 43063-906-42 | 43063090642 | 42 TABLET in 1 BOTTLE, PLASTIC (43063-906-42) | 42 tablet | 2019-02-22 | 0000-00-00 | No | No | Current |
| 43063-906-90 | 43063090690 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-906-90) | 90 tablet | 2018-11-14 | 0000-00-00 | No | No | Current |