Prescription drug · ANDA
Terbinafine (Terbinafine hydrochloride tablet) NDC 87564-010
Terbinafine hydrochloride 250 mg/1 · Tablet · Oral · Amerisyn LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87564-010-10 | 8756400101087564001010 | 100 TABLET in 1 BOTTLE (87564-010-10)Marketed from Aug 3, 2026 | |
| 87564-010-30 | 8756400103087564001030 | 30 TABLET in 1 BOTTLE (87564-010-30)Marketed from Aug 3, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 tablet
- Active ingredients
- Terbinafine hydrochloride — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amerisyn LLCNDC labeler code 87564
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076390
- Marketing start
- Listing expires
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 87564-010_584d1fba-8315-2afa-e063-6394a90a9564SPL ID 584d1fba-8315-2afa-e063-6394a90a9564SPL set ID 584d1fae-0120-49a0-e063-6394a90a36fcRxCUI 313222UNII 012C11ZU6GUPC 0387564010103
- 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
N487564001010followed by a unit qualifier and the quantityPackage 87564-0010-10. 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). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 87564-010
- What is NDC 87564-010?
- 87564-010 is the product NDC for Terbinafine (terbinafine hydrochloride tablet), Terbinafine hydrochloride 250 mg/1 tablet, listed with the FDA by Amerisyn LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Terbinafine (Terbinafine hydrochloride tablet).
- What is the active ingredient?
- Terbinafine hydrochloride.
- Who is the labeler?
- Amerisyn LLC, NDC labeler code 87564. 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 | 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 | NorthStar Rx LLC | 16714-795 | 16714-0795-0116714-0795-02 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-3575 | 50090-3575-0050090-3575-01 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-3654 | 50090-3654-0050090-3654-01 |
Other NDCs under ANDA 076390
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 Hydrochlorideterbinafine tablets 250 mg | Terbinafine hydrochloride 250 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-995 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Dr.Reddys Laboratories Limited | 55111-250 |
| Terbinafine Hydrochlorideterbinafine tablets 250 mg | Terbinafine hydrochloride 250 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-225 |