Prescription drug · ANDA
Terbinafine (Terbinafine hydrochloride) NDC 68788-7450
Terbinafine hydrochloride 250 mg/1 · Tablet · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68788-7450Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7450Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7450-1 | 68788745001 | 100 TABLET in 1 BOTTLE (68788-7450-1)Marketed from Dec 27, 2019 | |
| 68788-7450-3 | 68788745003 | 30 TABLET in 1 BOTTLE (68788-7450-3)Marketed from Dec 27, 2019 |
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
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- 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 68788-7450_7786aac6-13b9-44ab-a3c2-e4dabe65c0c1SPL ID 7786aac6-13b9-44ab-a3c2-e4dabe65c0c1
- 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
N468788745001followed by a unit qualifier and the quantityPackage 68788-7450-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68788-7450
- What is NDC 68788-7450?
- 68788-7450 is the product NDC for Terbinafine (terbinafine hydrochloride), Terbinafine hydrochloride 250 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 2 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 | 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 |
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 | 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 | American Health Packaging | 60687-909 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-079 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4873 |
| 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 | Proficient Rx LP | 71205-492 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1124 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2539 |
| Terbinafine | Terbinafine hydrochloride 250 mg/1 | TabletOral | direct rx | 72189-243 |
| Terbinafineterbinafine hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-394 |