Prescription drug · ANDA
Terbinafine (terbinafine hydrochloride) NDC 50090-3654
Terbinafine hydrochloride 250 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3654-0 | 50090365400 | 30 TABLET in 1 BOTTLE, PLASTIC (50090-3654-0)Marketed from Nov 28, 2014 | |
| 50090-3654-1 | 50090365401 | 90 TABLET in 1 BOTTLE (50090-3654-1)Marketed from Oct 11, 2018 |
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
- A-S Medication Solutions
- 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 50090-3654_96cc504c-9106-48d2-a614-81ad3a4e977cSPL ID 96cc504c-9106-48d2-a614-81ad3a4e977cSPL set ID 79a39fb1-12b7-4b1e-9f28-102af34d0459RxCUI 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
N450090365400followed by a unit qualifier and the quantityPackage 50090-3654-00. 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 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 | NorthStar Rx LLC | 16714-795 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Proficient Rx LP | 71205-061 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | American Health Packaging | 60687-909 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7450 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2539 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1124 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-394 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-3575 |
| Terbinafine | Terbinafine hydrochloride 250 mg/1 | TabletOral | direct rx | 72189-243 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4873 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Proficient Rx LP | 71205-492 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-079 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2941 |