Over-the-counter drug · ANDA
Terbinafine Hydrochloride NDC 63187-111
Terbinafine hydrochloride 1 g/100g · Cream · Topical · Proficient Rx LP
NDC codes
FDA NDC DirectoryProduct NDC (as listed)63187-111Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0111Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-111-15 | 6318701111563187011115 | 1 TUBE in 1 CARTON (63187-111-15) / 15 g in 1 TUBEMarketed from Dec 1, 2018 | |
| 63187-111-30 | 6318701113063187011130 | 1 TUBE in 1 CARTON (63187-111-30) / 30 g in 1 TUBEMarketed from Dec 1, 2018 |
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 hydrochloride
- Active ingredients
- Terbinafine hydrochloride — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Proficient Rx LPNDC labeler code 63187
- 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 63187-111_96ea8a54-d84e-4ac6-9ce1-2624f20a4992SPL ID 96ea8a54-d84e-4ac6-9ce1-2624f20a4992SPL set ID 76f7525d-2005-4da8-a795-50ede6236c68RxCUI 992528UNII 012C11ZU6GUPC 0363187111304
- 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
N463187011115followed by a unit qualifier and the quantityPackage 63187-0111-15. 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 63187-111
- What is NDC 63187-111?
- 63187-111 is the product NDC for Terbinafine Hydrochloride, Terbinafine hydrochloride 1 g/100g cream, listed with the FDA by Proficient Rx LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Terbinafine Hydrochloride.
- What is the active ingredient?
- Terbinafine hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. 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 Hydrochlorideterbinafine tablets 250 mg | Terbinafine hydrochloride 250 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-225 | 69292-0225-0169292-0225-30 |
| 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 |
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 |
|---|---|---|---|---|
| Antifungalterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Meijer Distribution Inc | 41250-080 |
| 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 | Preferred Pharmaceuticals, Inc | 68788-9814 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Cardinal Health, 110 dba LEADER | 70000-0338 |
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