terbinafine hydrochloride
- Product NDC
- 42043-410
- 11-digit product format
- 420430410
- Labeler code
- 42043
- Product ID
- 42043-410_b752c136-2fc5-40ad-8abb-3384c0ccbf2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- terbinafine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- OrchidPharma Inc
- Application
- ANDA078163
- Marketing category
- ANDA
- Marketing start
- 2020-10-01
- 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
- 2023-12-31
- 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 |
|---|---|---|---|---|---|
| 42043-410-01 | 2024-12-23 | C162847 | 48780-1 | 0191ceaa-6dc4-198a-e063-dbdaa90aec3e | 363cd62d-cc38-4fc3-8d4b-281bdb2a2369 |
| 42043-410-03 | 2024-12-23 | C162847 | 48780-1 | 0191ceaa-6dc4-198a-e063-dbdaa90aec3e | 363cd62d-cc38-4fc3-8d4b-281bdb2a2369 |
| 42043-410-01 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6dc4-198a-e063-dbdaa90aec3e | 363cd62d-cc38-4fc3-8d4b-281bdb2a2369 |
| 42043-410-03 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6dc4-198a-e063-dbdaa90aec3e | 363cd62d-cc38-4fc3-8d4b-281bdb2a2369 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42043-410-01 | EA - Each | 42043-410 | f491852b-64ad-4f9c-bdf1-7b75f1db8ee7 | 1 | 2021-02-05 |
| 42043-410-03 | EA - Each | 42043-410 | 8daab031-1d15-4ee9-9e58-e4bd77e66757 | 1 | 2021-02-05 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313222 | terbinafine HCl 250 MG Oral Tablet | PSN | 754f22ba-65af-4d03-bdc2-456e69dea493 | 102 |
| 313222 | terbinafine 250 MG Oral Tablet | SCD | 754f22ba-65af-4d03-bdc2-456e69dea493 | 102 |
| 313222 | terbinafine (as terbinafine HCl) 250 MG Oral Tablet | SY | 754f22ba-65af-4d03-bdc2-456e69dea493 | 102 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42043-410-01 | 42043041001 | 100 TABLET in 1 BOTTLE, PLASTIC (42043-410-01) | 100 tablet | 2020-10-01 | 0000-00-00 | No | No | Current |
| 42043-410-03 | 42043041003 | 30 TABLET in 1 BOTTLE, PLASTIC (42043-410-03) | 30 tablet | 2020-10-01 | 0000-00-00 | No | No | Current |