Prescription drug · ANDA
Ultramicrosize Griseofulvin (Ultramicrosize griseofulvin tablets) NDC 0115-1725
Griseofulvin 250 mg/1 · Tablet, Coated · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1725-01 | 0011517250100115172501 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1725-01)Marketed from Sep 29, 2014 | |
| 0115-1725-03 | 0011517250300115172503 | 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1725-03)Marketed from Sep 29, 2014 |
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 tablets
- Active ingredients
- Griseofulvin — 250 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204371
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Mitosis (Physiologic effect)Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 0115-1725_0fe90733-bebc-42d5-a098-8f53ad6fab67SPL ID 0fe90733-bebc-42d5-a098-8f53ad6fab67
- 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
N400115172501followed by a unit qualifier and the quantityPackage 00115-1725-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0115-1725
- What is NDC 0115-1725?
- 0115-1725 is the product NDC for Ultramicrosize Griseofulvin (ultramicrosize griseofulvin tablets), Griseofulvin 250 mg/1 tablet, coated, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ultramicrosize Griseofulvin (Ultramicrosize Griseofulvin Tablets).
- What is the active ingredient?
- Griseofulvin.
- Who is the labeler?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 Griseofulvin | Griseofulvin 250 mg/1 | Tablet, CoatedOral | Sandoz Inc | 0781-5828 | 00781-5828-0100781-5828-05 |
| Ultramicrosize Griseofulvinultramicrosize griseofulvin tablets | Griseofulvin 125 mg/1 | Tablet, CoatedOral | Amneal Pharmaceuticals of New York LLC | 0115-1724 | 00115-1724-0100115-1724-02 |
| Ultramicrosize 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 204371
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 Griseofulvinultramicrosize griseofulvin tablets | Griseofulvin 125 mg/1 | Tablet, CoatedOral | Amneal Pharmaceuticals of New York LLC | 0115-1724 |