Prescription drug · ANDA
Misoprostol NDC 50268-555
Misoprostol 200 ug/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-555-60 | 50268055560 | 60 TABLET in 1 BOTTLE (50268-555-60)Marketed from Oct 3, 2024 |
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)
- Misoprostol
- Generic name (nonproprietary)
- misoprostol
- Active ingredients
- Misoprostol — 200 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210201
- Marketing start
- Listing expires
- Other FDA classes
- Synthetic (Chemical structure)
- Identifiers
- Product ID 50268-555_47e7448c-f84c-4a4c-e063-6394a90ad262SPL ID 47e7448c-f84c-4a4c-e063-6394a90ad262SPL set ID 2396e9c0-3742-69cf-e063-6394a90adb13RxCUI 317128UNII 0E43V0BB57UPC 0350268555607
- Pharmacologic class
- Prostaglandin E1 Analog
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
N450268055560followed by a unit qualifier and the quantityPackage 50268-0555-60. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 210201
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 |
|---|---|---|---|---|
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | GenBioPro, Inc. | 43393-024 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | GenBioPro, Inc. | 43393-200 |