Prescription drug · ANDA
terbinafine hydrochloride NDC 71335-9677
Terbinafine hydrochloride 250 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9677-1 | 71335967701 | 30 TABLET in 1 BOTTLE, PLASTIC (71335-9677-1)Marketed from Jun 6, 2023 | |
| 71335-9677-2 | 71335967702 | 60 TABLET in 1 BOTTLE, PLASTIC (71335-9677-2)Marketed from Feb 3, 2025 | |
| 71335-9677-3 | 71335967703 | 90 TABLET in 1 BOTTLE, PLASTIC (71335-9677-3)Marketed from Aug 30, 2023 | |
| 71335-9677-4 | 71335967704 | 100 TABLET in 1 BOTTLE, PLASTIC (71335-9677-4)Marketed from Feb 3, 2025 | |
| 71335-9677-5 | 71335967705 | 7 TABLET in 1 BOTTLE, PLASTIC (71335-9677-5)Marketed from Feb 3, 2025 | |
| 71335-9677-6 | 71335967706 | 40 TABLET in 1 BOTTLE, PLASTIC (71335-9677-6)Marketed from Feb 3, 2025 | |
| 71335-9677-7 | 71335967707 | 45 TABLET in 1 BOTTLE, PLASTIC (71335-9677-7)Marketed from Jun 26, 2023 | |
| 71335-9677-8 | 71335967708 | 14 TABLET in 1 BOTTLE, PLASTIC (71335-9677-8)Marketed from May 10, 2023 | |
| 71335-9677-9 | 71335967709 | 28 TABLET in 1 BOTTLE, PLASTIC (71335-9677-9)Marketed from May 10, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- terbinafine hydrochloride
- Generic name (nonproprietary)
- terbinafine hydrochloride
- Active ingredients
- Terbinafine hydrochloride — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078163
- Marketing start
- Listing expires
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645dSPL ID ebbb6769-54f5-415e-a685-0c6baf35645dSPL set ID 5a921005-304e-4f5b-b9ba-681749e2499bRxCUI 313222UNII 012C11ZU6G
- Pharmacologic class
- Allylamine Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471335967701followed by a unit qualifier and the quantityPackage 71335-9677-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078163
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| terbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Bionpharma Inc. | 69452-351 |
| terbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3907 |
| terbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Proficient Rx LP | 82804-220 |
| terbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-7300 |