Prescription drug · ANDA
Mifepristone NDC 43393-001
Mifepristone 200 mg/1 · Tablet · Oral · GenBioPro, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43393-001-06 | 43393000106 | 6 CARTON in 1 PACKAGE (43393-001-06) / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01)Marketed from May 1, 2019 |
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)
- Mifepristone
- Generic name (nonproprietary)
- mifepristone
- Active ingredients
- Mifepristone — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- GenBioPro, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091178
- Marketing start
- Listing expires
- Other FDA classes
- Progestational Hormone Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43393-001_539725c1-189c-1934-e063-6294a90ac3c0SPL ID 539725c1-189c-1934-e063-6294a90ac3c0SPL set ID b63fad9b-7f12-4400-9019-b0586054e534RxCUI 311704UNII 320T6RNW1FUPC 0343393001019
- Pharmacologic class
- Progestin Antagonist
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
N443393000106followed by a unit qualifier and the quantityPackage 43393-0001-06. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Mifepristone tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. Mifepristone tablets, 200 mg is a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. ( 1 )
Excerpt only. Read the full label for complete information.