Prescription drug · ANDA
Ultramicrosize Griseofulvin NDC 0781-5828
Griseofulvin 250 mg/1 · Tablet, Coated · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-5828-01 | 0078158280100781582801 | 100 TABLET, COATED in 1 BOTTLE (0781-5828-01)Marketed from Apr 1, 2020 | |
| 0781-5828-05 | 0078158280500781582805 | 500 TABLET, COATED in 1 BOTTLE (0781-5828-05)Marketed from Apr 1, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Ultramicrosize Griseofulvin
- Generic name (nonproprietary)
- ultramicrosize griseofulvin
- Active ingredients
- Griseofulvin — 250 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202805
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Mitosis (Physiologic effect)Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 0781-5828_6d66c19d-0069-4a47-a45c-567aa0398135SPL ID 6d66c19d-0069-4a47-a45c-567aa0398135SPL set ID f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebdRxCUI 239239, 242831UNII 32HRV3E3D5UPC 0307815828011, 0307815827014
- 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
N400781582801followed by a unit qualifier and the quantityPackage 00781-5828-01. 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 Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete’s foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber’s itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audou…
Excerpt only. Read the full label for complete information.
About NDC 0781-5828
- What is NDC 0781-5828?
- 0781-5828 is the product NDC for Ultramicrosize Griseofulvin, Griseofulvin 250 mg/1 tablet, coated, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ultramicrosize Griseofulvin.
- What is the active ingredient?
- Griseofulvin.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ultramicrosize Griseofulvin?
- 11 other product NDCs are listed under this name. See all Ultramicrosize Griseofulvin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ultramicrosize Griseofulvin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ultramicrosize Griseofulvingriseofulvin | Griseofulvin 125 mg/1 | TabletOral | Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-863 | 23155-0863-01 |
| Ultramicrosize Griseofulvingriseofulvin | Griseofulvin 250 mg/1 | TabletOral | Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-864 | 23155-0864-01 |
| Ultramicrosize Griseofulvin | Griseofulvin 125 mg/1 | Tablet, CoatedOral | Sandoz Inc | 0781-5827 | 00781-5827-0100781-5827-05 |
| Ultramicrosize Griseofulvinultramicrosize griseofulvin tablets | Griseofulvin 125 mg/1 | Tablet, CoatedOral | Amneal Pharmaceuticals of New York LLC | 0115-1724 | 00115-1724-0100115-1724-02 |
| Ultramicrosize Griseofulvinultramicrosize griseofulvin tablets | Griseofulvin 250 mg/1 | Tablet, CoatedOral | Amneal Pharmaceuticals of New York LLC | 0115-1725 | 00115-1725-0100115-1725-03 |
| Ultramicrosize Griseofulvin | Griseofulvin 125 mg/1 | TabletOral | Sigmapharm Laboratories, LLC | 42794-013 | 42794-0013-08 |
| Ultramicrosize Griseofulvin | Griseofulvin 250 mg/1 | TabletOral | Sigmapharm Laboratories, LLC | 42794-014 | 42794-0014-08 |
| Ultramicrosize Griseofulvingriseofulvin | Griseofulvin 125 mg/1 | TabletOral | Chartwell RX, LLC. | 62135-494 | 62135-0494-0162135-0494-30 |
| Ultramicrosize Griseofulvingriseofulvin | Griseofulvin 250 mg/1 | TabletOral | Chartwell RX, LLC. | 62135-495 | 62135-0495-0162135-0495-30 |
| Ultramicrosize Griseofulvin | Griseofulvin 165 mg/1 | TabletOral | Chartwell RX, LLC | 62135-501 | 62135-0501-30 |
Other NDCs under ANDA 202805
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 |
|---|---|---|---|---|
| Ultramicrosize Griseofulvin | Griseofulvin 125 mg/1 | Tablet, CoatedOral | Sandoz Inc | 0781-5827 |