Over-the-counter drug · ANDA
Antifungal (Terbinafine hydrochloride) NDC 41250-080
Terbinafine hydrochloride 1 g/100g · Cream · Topical · Meijer Distribution Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41250-080-02 | 4125000800241250008002 | 1 TUBE in 1 CARTON (41250-080-02) / 30 g in 1 TUBEMarketed from Dec 12, 2012 |
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)
- Antifungal
- Generic name (nonproprietary)
- terbinafine hydrochloride
- Active ingredients
- Terbinafine hydrochloride — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Meijer Distribution IncNDC labeler code 41250
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077511
- Marketing start
- Listing expires
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 41250-080_38f98fba-d07b-1b27-e063-6394a90ab11aSPL ID 38f98fba-d07b-1b27-e063-6394a90ab11aSPL set ID 9daf3136-74b6-4410-8256-cbc9dd700f61RxCUI 992528UNII 012C11ZU6GUPC 0713733162067
- 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N441250008002followed by a unit qualifier and the quantityPackage 41250-0080-02. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses cures most athlete's foot (tinea pedis) cures most jock itch (tinea cruris) and ringworm (tinea corporis) relieves itching, burning, cracking and scaling which accompany these conditions
Excerpt only. Read the full label for complete information.
About NDC 41250-080
- What is NDC 41250-080?
- 41250-080 is the product NDC for Antifungal (terbinafine hydrochloride), Terbinafine hydrochloride 1 g/100g cream, listed with the FDA by Meijer Distribution Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Antifungal (Terbinafine Hydrochloride).
- What is the active ingredient?
- Terbinafine hydrochloride.
- Who is the labeler?
- Meijer Distribution Inc, NDC labeler code 41250. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Antifungal?
- 9 other product NDCs are listed under this name. See all Antifungal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Antifungal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Antifungalmiconazole nitrate | Miconazole nitrate 2 g/100g | CreamTopical | Dynarex Corporation | 67777-710 | 67777-0710-0267777-0710-05 |
| Antifungalclotrimazole | Clotrimazole 1 g/100g | CreamTopical | Dynarex Corporation | 67777-727 | 67777-0727-0267777-0727-05 |
| Antifungalclotrimazole | Clotrimazole 1 g/100g | CreamTopical | VIVE HEALTH LLC | 84722-3059 | 84722-3059-00 |
| Antifungalmiconazole | Miconazole 2 g/100g | OintmentTopical | VIVE HEALTH LLC | 84722-3060 | 84722-3060-00 |
| Antifungalmiconazole | Miconazole 2 g/100g | PowderTopical | VIVE HEALTH LLC | 84722-3057 | 84722-3057-01 |
| Antifungalclotrimazole | Clotrimazole 10 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-094 | 21922-0094-0421922-0094-05 |
| Antifungalmiconazole nitrate | Miconazole nitrate 20 mg/g | PowderTopical | Advanced Rx LLC | 80513-771 | 80513-0771-03 |
| Antifungaltolnaftate 1% | Tolnaftate 1 g/100g | CreamTopical | Chain Drug Marketing Association Inc. | 83324-049 | 83324-0049-01 |
| Antifungalundecylenic acid | Undecylenic acid 25 g/100mL | LiquidTopical | Chemco Corporation | 49283-250 | 49283-0250-05 |
Other NDCs under ANDA 077511
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 |
|---|---|---|---|---|
| Athletes Footterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Rite Aid Corporation | 11822-0080 |
| Athletes Footterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | H E B | 37808-080 |
| Athletes Footterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Publix Super Markets Inc. | 56062-080 |
| Curist Antifungal Reliefterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Little Pharma, Inc. | 72559-035 |
| Cvsterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | CVS Pharmacy | 59779-523 |
| CVS Pharmacy Athletes Footterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | CVS Pharmacy | 59779-080 |
| equate Athletes Footterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Wal-Mart Stores Inc | 49035-080 |
| Good Neighbor Pharmacyterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | AmerisourceBergen | 24385-524 |
| Good Neighbor Pharmacyterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-4044 |
| Kroger Antifungalterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Kroger Company | 30142-080 |
| Silka Antifungalterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Genomma Lab USA, Inc. | 50066-080 |
| Silka Jock Itchterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Genomma Lab USA, Inc. | 50066-208 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | WALGREEN COMPANY | 0363-4502 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | A-S Medication Solutions | 50090-1278 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | A-S Medication Solutions | 50090-5810 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-2080 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-2140 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Proficient Rx LP | 63187-111 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Preferred Pharmaceuticals, Inc | 68788-9814 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Cardinal Health, 110 dba LEADER | 70000-0338 |
Showing 20 of 23.