Prescription drug · ANDA
Griseofulvin (griseofulvin (microsize)) NDC 62135-968
Griseofulvin 125 mg/5mL · Suspension · Oral · Chartwell RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-968-41 | 62135096841 | 120 mL in 1 BOTTLE (62135-968-41)Marketed from Aug 26, 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)
- Griseofulvin
- Generic name (nonproprietary)
- griseofulvin (microsize)
- Active ingredients
- Griseofulvin — 125 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Chartwell RX, LLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065200
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Mitosis (Physiologic effect)Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 62135-968_2589e155-f098-67fc-e063-6294a90a20b8SPL ID 2589e155-f098-67fc-e063-6294a90a20b8SPL set ID 9f7e4ecf-f992-42c5-81ea-91e6587b22a5RxCUI 239238UNII 32HRV3E3D5UPC 0362135968410
- Pharmacologic class
- Tubulin Inhibiting Agent
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
N462135096841followed by a unit qualifier and the quantityPackage 62135-0968-41. 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)
Indications and Usage Major indications for Griseofulvin Oral Suspension, USP are: Tinea capitis (ringworm of the scalp) Tinea corporis (ringworm of the body) Tinea pedis (athlete's foot) Tinea unguium (onychomycosis; ringworm of the nails) Tinea cruris (ringworm of the thigh) Tinea barbae (barber’s itch) Griseofulvin Oral Suspension, USP inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as: Trichophyton rubrum Trichophyton tonsurans Trichophyton mentagrophytes Trichophyton interdigitalis Trichophyton verrucosum Trichophyton sulphureum Trichophyton schoenleini Microsporum audouini Microsporum canis Microsporum gypseum Epid…
Excerpt only. Read the full label for complete information.