Terbinafine Hydrochloride
- Product NDC
- 21695-630
- 11-digit product format
- 216950630
- Labeler code
- 21695
- Product ID
- 21695-630_dfb8fc2d-4899-4891-a985-755fbdf1d525
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA077533
- Marketing category
- ANDA
- Marketing start
- 2007-07-02
- Marketing end
- 0000-00-00
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine [CS],Allylamine Antifungal [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 55a24767-1759-5f6a-8888-ea4aa0adac21 | Product name | 1 | 20140508 |
| db9701af-cb4f-b8ba-d282-6bc5b6b7c467 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-630-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4aa9-48b1-e053-8cdaa90a720a | Terbinafine Hydrochloride Tablets |
| 21695-630-42 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4aa9-48b1-e053-8cdaa90a720a | Terbinafine Hydrochloride Tablets |
| 21695-630-45 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4aa9-48b1-e053-8cdaa90a720a | Terbinafine Hydrochloride Tablets |
| 21695-630-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4aa9-48b1-e053-8cdaa90a720a | Terbinafine Hydrochloride Tablets |
| 21695-630-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4aa9-48b1-e053-8cdaa90a720a | Terbinafine Hydrochloride Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-630-30 | Terbinafine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-630-42 | Terbinafine Hydrochloride | 42 in 1 BOTTLE | TABLET | 42 | 1 | |
| 21695-630-45 | Terbinafine Hydrochloride | 45 in 1 BOTTLE | TABLET | 45 | 1 | |
| 21695-630-60 | Terbinafine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 21695-630-90 | Terbinafine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-630-30 | EA - Each | 21695-630 | 6bc1aeb2-7708-447f-a769-d0256e32299d | 1 | 2012-07-24 |
| 21695-630-42 | EA - Each | 21695-630 | 0e383a1c-f704-44f2-b94b-d6024babeca9 | 1 | 2012-07-24 |
| 21695-630-45 | EA - Each | 21695-630 | 881aa1ec-2fc9-497a-b00c-387c4eb3f689 | 1 | 2012-07-24 |
| 21695-630-60 | EA - Each | 21695-630 | a3fa2e99-fbec-4073-9af6-1fe022c48e72 | 1 | 2012-07-24 |
| 21695-630-90 | EA - Each | 21695-630 | f1e13408-780f-4135-98ce-1899a7fb75b8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TERBINAFINE HYDROCHLORIDE | ACTIVE INGREDIENT | 012C11ZU6G | TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| TERBINAFINE | ACTIVE MOIETY | G7RIW8S0XP | TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313222 | terbinafine HCl 250 MG Oral Tablet | PSN | dfb8fc2d-4899-4891-a985-755fbdf1d525 | 1 |
| 313222 | terbinafine 250 MG Oral Tablet | SCD | dfb8fc2d-4899-4891-a985-755fbdf1d525 | 1 |
| 313222 | terbinafine (as terbinafine HCl) 250 MG Oral Tablet | SY | dfb8fc2d-4899-4891-a985-755fbdf1d525 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-630-30 | 21695063030 | 30 in 1 BOTTLE | Historical |
| 21695-630-42 | 21695063042 | 42 in 1 BOTTLE | Historical |
| 21695-630-45 | 21695063045 | 45 in 1 BOTTLE | Historical |
| 21695-630-60 | 21695063060 | 60 in 1 BOTTLE | Historical |
| 21695-630-90 | 21695063090 | 90 in 1 BOTTLE | Historical |