Prescription drug · ANDA
Terbinafine (Terbinafine hydrochloride) NDC 71335-1124
Terbinafine hydrochloride 250 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1124-1 | 71335112401 | 30 TABLET in 1 BOTTLE (71335-1124-1)Marketed from Feb 26, 2019 | |
| 71335-1124-2 | 71335112402 | 60 TABLET in 1 BOTTLE (71335-1124-2)Marketed from May 30, 2024 | |
| 71335-1124-3 | 71335112403 | 90 TABLET in 1 BOTTLE (71335-1124-3)Marketed from Mar 1, 2021 | |
| 71335-1124-4 | 71335112404 | 100 TABLET in 1 BOTTLE (71335-1124-4)Marketed from May 30, 2024 | |
| 71335-1124-5 | 71335112405 | 7 TABLET in 1 BOTTLE (71335-1124-5)Marketed from May 30, 2024 | |
| 71335-1124-6 | 71335112406 | 40 TABLET in 1 BOTTLE (71335-1124-6)Marketed from May 30, 2024 | |
| 71335-1124-7 | 71335112407 | 45 TABLET in 1 BOTTLE (71335-1124-7)Marketed from Feb 27, 2019 | |
| 71335-1124-8 | 71335112408 | 14 TABLET in 1 BOTTLE (71335-1124-8)Marketed from Nov 14, 2019 | |
| 71335-1124-9 | 71335112409 | 28 TABLET in 1 BOTTLE (71335-1124-9)Marketed from May 30, 2024 |
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
- Generic name (nonproprietary)
- terbinafine hydrochloride
- Active ingredients
- Terbinafine hydrochloride — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078297
- Marketing start
- Listing expires
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818SPL ID 58d188ab-ecb7-4e4c-b6eb-f70773aa8818SPL set ID 294bc1af-50e3-4bff-8d48-321e673033ceRxCUI 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
N471335112401followed by a unit qualifier and the quantityPackage 71335-1124-01. 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.
About NDC 71335-1124
- What is NDC 71335-1124?
- 71335-1124 is the product NDC for Terbinafine (terbinafine hydrochloride), Terbinafine hydrochloride 250 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 9 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Terbinafine (Terbinafine Hydrochloride).
- What is the active ingredient?
- Terbinafine hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Terbinafine?
- 19 other product NDCs are listed under this name. See all Terbinafine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Terbinafine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Terbinafineterbinafine hydrochloride tablet | Terbinafine hydrochloride 250 mg/1 | TabletOral | Amerisyn LLC | 87564-010 | 87564-0010-1087564-0010-30 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | American Health Packaging | 60687-909 | 60687-0909-21 |
| Terbinafine | Terbinafine hydrochloride 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4421 | 70518-4421-0070518-4421-0170518-4421-02+1 more |
| Terbinafine | Terbinafine hydrochloride 250 mg/1 | TabletOral | direct rx | 72189-243 | 72189-0243-30 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2941 | 70518-2941-00 |
| Terbinafine | Terbinafine hydrochloride 250 mg/1 | TabletOral | Cipla USA Inc. | 69097-859 | 69097-0859-0269097-0859-0769097-0859-12 |
| Terbinafine | Terbinafine hydrochloride 250 1/1 | TabletOral | Proficient Rx LP | 71205-152 | 71205-0152-1571205-0152-3071205-0152-35+3 more |
| Terbinafine | Terbinafine hydrochloride 250 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-209 | 76282-0209-0176282-0209-0576282-0209-30 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Proficient Rx LP | 71205-061 | 71205-0061-30 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | NorthStar Rx LLC | 16714-795 | 16714-0795-0116714-0795-02 |
Other NDCs under ANDA 078297
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 |
|---|---|---|---|---|
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2941 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Proficient Rx LP | 71205-061 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | NorthStar Rx LLC | 16714-795 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7450 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | American Health Packaging | 60687-909 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2539 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-394 |
| Terbinafine | Terbinafine hydrochloride 250 mg/1 | TabletOral | direct rx | 72189-243 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Proficient Rx LP | 71205-492 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4873 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-3575 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-3654 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-079 |