Terbinafine Hydrochloride
- Product NDC
- 60429-222
- 11-digit product format
- 604290222
- Labeler code
- 60429
- Product ID
- 60429-222_44747bdd-3b26-7fe5-e063-6294a90a816d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA077714
- Marketing category
- ANDA
- Marketing start
- 2010-06-04
- Marketing end
- 2027-05-31
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine Antifungal [EPC], Allylamine [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Terbinafine Hydrochloride
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 |
|---|
| 60429-222-30 | Terbinafine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Terbinafine Hydrochloride | ACTIVE INGREDIENT | 012C11ZU6G | TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| Terbinafine | ACTIVE MOIETY | G7RIW8S0XP | TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| Sodium Starch Glycolate Type A Potato | INACTIVE INGREDIENT | 5856J3G2A2 | TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60429-222 | TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20240817_b43e4644-024c-4aa6-b403-19152c785802.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 |
|---|
| 60429-222-30 | 60429022230 | 30 TABLET in 1 BOTTLE (60429-222-30) | 30 tablet | 2012-08-22 | 2027-05-31 | No | No | Current |