Terbinafine Hydrochloride
- Product NDC
- 55111-250
- 11-digit product format
- 551110250
- Labeler code
- 55111
- Product ID
- 55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Limited
- Application
- ANDA076390
- Marketing category
- ANDA
- Marketing start
- 2007-07-02
- 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 |
|---|
| 55111-250-01 | Terbinafine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 55111-250-05 | Terbinafine Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
| 55111-250-30 | Terbinafine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 55111-250-78 | Terbinafine Hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | | 8 |
| 55111-250-79 | Terbinafine Hydrochloride | 10 in 1 CARTON | TABLET | 10 | | 8 |
| 55111-250-90 | Terbinafine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-250 | TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) TABLET [DR.REDDYS LABORATORIES LIMITED] | 8 | Current NDC, Legacy NDC, 6 package rows | 20241222_e0b309a5-bebe-c6da-2847-bda21aa488b1.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 |
|---|
| 55111-250-01 | 55111025001 | 100 TABLET in 1 BOTTLE (55111-250-01) | 100 tablet | 2007-07-02 | 0000-00-00 | No | No | Current |
| 55111-250-05 | 55111025005 | 500 TABLET in 1 BOTTLE (55111-250-05) | 500 tablet | 2007-07-02 | 0000-00-00 | No | No | Current |
| 55111-250-30 | 55111025030 | 30 TABLET in 1 BOTTLE (55111-250-30) | 30 tablet | 2007-07-02 | 0000-00-00 | No | No | Current |
| 55111-250-78 | 55111025078 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 55111-250-79 | 55111025079 | 10 BLISTER PACK in 1 CARTON (55111-250-79) / 10 TABLET in 1 BLISTER PACK (55111-250-78) | 10 blister pack | 2007-07-02 | 0000-00-00 | No | No | Current |
| 55111-250-90 | 55111025090 | 90 TABLET in 1 BOTTLE (55111-250-90) | 90 tablet | 2007-07-02 | 0000-00-00 | No | No | Current |