Prescription drug · ANDA
Terbinafine Hydrochloride (Terbinafine tablets 250 mg) NDC 69292-225
Terbinafine hydrochloride 250 mg/1 · Tablet · Oral · Amici Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69292-225-01 | 6929202250169292022501 | 100 TABLET in 1 BOTTLE (69292-225-01)Marketed from Feb 18, 2026 | |
| 69292-225-30 | 6929202253069292022530 | 30 TABLET in 1 BOTTLE (69292-225-30)Marketed from Feb 18, 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 Hydrochloride
- Generic name (nonproprietary)
- terbinafine tablets 250 mg
- Active ingredients
- Terbinafine hydrochloride — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amici Pharma, Inc.NDC labeler code 69292
- 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 69292-225_75074aee-6269-496a-99c9-1c0de09f9f50SPL ID 75074aee-6269-496a-99c9-1c0de09f9f50SPL set ID dd8724e9-bef9-4258-b536-9c6d872c3bf8RxCUI 313222UNII 012C11ZU6GUPC 0369292225301, 0369292225011
- 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
N469292022501followed by a unit qualifier and the quantityPackage 69292-0225-01. 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 an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) (1) 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.
Excerpt only. Read the full label for complete information.
About NDC 69292-225
- What is NDC 69292-225?
- 69292-225 is the product NDC for Terbinafine Hydrochloride (terbinafine tablets 250 mg), Terbinafine hydrochloride 250 mg/1 tablet, listed with the FDA by Amici Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Terbinafine Hydrochloride (Terbinafine Tablets 250 mg).
- What is the active ingredient?
- Terbinafine hydrochloride.
- Who is the labeler?
- Amici Pharma, Inc., NDC labeler code 69292. 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 Hydrochloride?
- 30 other product NDCs are listed under this name. See all Terbinafine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Terbinafine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Scholl's Wellness Company LLC | 73469-7215 | 73469-7215-02 |
| terbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3907 | 70518-3907-0170518-3907-03 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | WALGREEN COMPANY | 0363-4502 | 00363-4502-02 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | STRATEGIC SOURCING SERVICES LLC | 70677-1003 | 70677-1003-01 |
| terbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-7300 | 50090-7300-0050090-7300-01 |
| terbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Bionpharma Inc. | 69452-351 | 69452-0351-1369452-0351-20 |
| terbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9677 | 71335-9677-0171335-9677-0271335-9677-03+6 more |
| terbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Proficient Rx LP | 82804-220 | 82804-0220-3082804-0220-42 |
| Terbinafine Hydrochlorideterbinafine tablets 250 mg | Terbinafine hydrochloride 250 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2381 | 68071-2381-03 |
| Terbinafine Hydrochlorideterbinafine tablets 250 mg | Terbinafine hydrochloride 250 mg/1 | TabletOral | Cipla USA Inc. | 69097-731 | 69097-0731-0269097-0731-07 |
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 |
|---|---|---|---|---|
| Terbinafineterbinafine hydrochloride tablet | Terbinafine hydrochloride 250 mg/1 | TabletOral | Amerisyn LLC | 87564-010 |
| 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 |