Prescription drug · ANDA
Griseofulvin MICROSIZE (Griseofulvin) NDC 62135-496
Griseofulvin 500 mg/1 · Tablet · Oral · Chartwell RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-496-01 | 6213504960162135049601 | 100 TABLET in 1 BOTTLE (62135-496-01)Marketed from Dec 31, 2020 | |
| 62135-496-30 | 6213504963062135049630 | 30 TABLET in 1 BOTTLE (62135-496-30)Marketed from Dec 31, 2020 |
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 MICROSIZE
- Generic name (nonproprietary)
- griseofulvin
- Active ingredients
- Griseofulvin — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC.NDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 060569
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Mitosis (Physiologic effect)Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 62135-496_2589e87e-f74c-cbf4-e063-6394a90a402fSPL ID 2589e87e-f74c-cbf4-e063-6394a90a402fSPL set ID 6902a976-b0c5-48a4-8d50-984002be6c3aRxCUI 310600UNII 32HRV3E3D5UPC 0362135496302
- 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
N462135049601followed by a unit qualifier and the quantityPackage 62135-0496-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Griseofulvin tablets, USP are indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis Tinea pedis Tinea cruris Tinea barbae Tinea capitis Tinea unguium when caused by one or more of the following species of fungi: Epidermophyton floccosum Microsporum audouinii Microsporum canis Microsporum gypseum Trichophyton crateriform Trichophyton gallinae Trichophyton interdigitalis Trichophyton megnini Trichophyton mentagrophytes Trichophyton rubrum Trichophyton schoenleini Trichophyton sulphureum Trichophyton tonsurans Trichophyton verrucosum Note: Prior to therapy, a dermatophyte should …
Excerpt only. Read the full label for complete information.
About NDC 62135-496
- What is NDC 62135-496?
- 62135-496 is the product NDC for Griseofulvin MICROSIZE (griseofulvin), Griseofulvin 500 mg/1 tablet, listed with the FDA by Chartwell RX, LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Griseofulvin MICROSIZE (Griseofulvin).
- What is the active ingredient?
- Griseofulvin.
- Who is the labeler?
- Chartwell RX, LLC., NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Griseofulvin MICROSIZE?
- 1 other product NDC are listed under this name. See all Griseofulvin MICROSIZE NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Griseofulvin MICROSIZE products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Griseofulvin Microsizegriseofulvin | Griseofulvin 500 mg/1 | TabletOral | Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-865 | 23155-0865-01 |
Other NDCs under ANDA 060569
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 |
|---|---|---|---|---|
| Griseofulvin Microsizegriseofulvin | Griseofulvin 500 mg/1 | TabletOral | Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-865 |