TERBINAFINE HYDROCHLORIDE
- Product NDC
- 69097-731
- 11-digit product format
- 690970731
- Labeler code
- 69097
- Product ID
- 69097-731_feb4ee13-5f95-4a62-8395-55bad95c424b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Tablets 250 mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA077137
- Marketing category
- ANDA
- Marketing start
- 2021-01-08
- 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 |
|---|
| 69097-731-02 | TERBINAFINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 69097-731-07 | TERBINAFINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-731 | TERBINAFINE HYDROCHLORIDE (TERBINAFINE TABLETS 250 MG) TABLET [CIPLA USA INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210109_daf41866-6f2b-4483-b575-456becd6e85f.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 |
|---|
| 69097-731-02 | 69097073102 | 30 TABLET in 1 BOTTLE (69097-731-02) | 30 tablet | 2021-01-08 | 0000-00-00 | No | No | Current |
| 69097-731-07 | 69097073107 | 100 TABLET in 1 BOTTLE (69097-731-07) | 100 tablet | 2021-01-08 | 0000-00-00 | No | No | Current |