Terbinafine Hydrochloride
- Product NDC
- 63629-2807
- 11-digit product format
- 636292807
- Labeler code
- 63629
- Product ID
- 63629-2807_653ab04e-0a11-415d-bf8b-4c64228066d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077533
- Marketing category
- ANDA
- Marketing start
- 2011-01-01
- Marketing end
- 0000-00-00
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine [CS],Allylamine Antifungal [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63629-2807-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c12a-f424-e053-dadaa90a57ce | Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992 |
| 63629-2807-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c12a-f424-e053-dadaa90a57ce | Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992 |
| 63629-2807-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c12a-f424-e053-dadaa90a57ce | Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992 |
| 63629-2807-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c12a-f424-e053-dadaa90a57ce | Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992 |
| 63629-2807-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c12a-f424-e053-dadaa90a57ce | Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992 |
| 63629-2807-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c12a-f424-e053-dadaa90a57ce | Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992 |
| 63629-2807-7 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c12a-f424-e053-dadaa90a57ce | Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992 |
| 63629-2807-8 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c12a-f424-e053-dadaa90a57ce | Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-2807-1 | Terbinafine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 63629-2807-2 | Terbinafine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 63629-2807-3 | Terbinafine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
| 63629-2807-4 | Terbinafine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 63629-2807-5 | Terbinafine Hydrochloride | 7 in 1 BOTTLE | TABLET | 7 | | 6 |
| 63629-2807-6 | Terbinafine Hydrochloride | 40 in 1 BOTTLE | TABLET | 40 | | 6 |
| 63629-2807-7 | Terbinafine Hydrochloride | 45 in 1 BOTTLE | TABLET | 45 | | 6 |
| 63629-2807-8 | Terbinafine Hydrochloride | 14 in 1 BOTTLE | TABLET | 14 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-2807 | TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [BRYANT RANCH PREPACK] | 6 | Legacy NDC, 8 package rows | 20180307_d3592751-686b-48bd-a8d4-14c86bbcf510.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 63629-2807-1 | 63629280701 | 30 in 1 BOTTLE | Historical |
| 63629-2807-2 | 63629280702 | 60 in 1 BOTTLE | Historical |
| 63629-2807-3 | 63629280703 | 90 in 1 BOTTLE | Historical |
| 63629-2807-4 | 63629280704 | 100 in 1 BOTTLE | Historical |
| 63629-2807-5 | 63629280705 | 7 in 1 BOTTLE | Historical |
| 63629-2807-6 | 63629280706 | 40 in 1 BOTTLE | Historical |
| 63629-2807-7 | 63629280707 | 45 in 1 BOTTLE | Historical |
| 63629-2807-8 | 63629280708 | 14 in 1 BOTTLE | Historical |