Over-the-counter drug · ANDA
Silka Jock Itch (Terbinafine hydrochloride) NDC 50066-208
Terbinafine hydrochloride 1 g/100g · Cream · Topical · Genomma Lab USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50066-208-05 | 5006602080550066020805 | 1 TUBE in 1 CARTON (50066-208-05) / 15 g in 1 TUBEMarketed from Dec 20, 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)
- Silka Jock ItchSuffix: Jock Itch
- Generic name (nonproprietary)
- terbinafine hydrochloride
- Active ingredients
- Terbinafine hydrochloride — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Genomma Lab USA, Inc.NDC labeler code 50066
- 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 50066-208_38f65202-ed21-e74d-e063-6294a90a2882SPL ID 38f65202-ed21-e74d-e063-6294a90a2882SPL set ID 326d8586-042f-44f8-8530-e46b7b777bc3RxCUI 992528, 1739221UNII 012C11ZU6G
- 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
N450066020805followed by a unit qualifier and the quantityPackage 50066-0208-05. 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 jock itch (tinea cruris) relieves itching, burning, cracking and scaling which accompany this condition
Excerpt only. Read the full label for complete information.
About NDC 50066-208
- What is NDC 50066-208?
- 50066-208 is the product NDC for Silka Jock Itch (terbinafine hydrochloride), Terbinafine hydrochloride 1 g/100g cream, listed with the FDA by Genomma Lab USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Silka Jock Itch (Terbinafine Hydrochloride).
- What is the active ingredient?
- Terbinafine hydrochloride.
- Who is the labeler?
- Genomma Lab USA, Inc., NDC labeler code 50066. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Silka Jock Itch?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
| 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 |
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