Prescription drug · ANDA
Terbinafine Hydrochloride (terbinafine tablets 250 mg) NDC 69097-731
Terbinafine hydrochloride 250 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-731-02 | 69097073102 | 30 TABLET in 1 BOTTLE (69097-731-02)Marketed from Jan 8, 2021 | |
| 69097-731-07 | 69097073107 | 100 TABLET in 1 BOTTLE (69097-731-07)Marketed from Jan 8, 2021 |
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
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077137
- Marketing start
- Listing expires
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 69097-731_feb4ee13-5f95-4a62-8395-55bad95c424bSPL ID feb4ee13-5f95-4a62-8395-55bad95c424bSPL set ID daf41866-6f2b-4483-b575-456becd6e85fRxCUI 313222UNII 012C11ZU6GUPC 0369097731021
- 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
N469097073102followed by a unit qualifier and the quantityPackage 69097-0731-02. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.