Prescription drug · ANDA
Misoprostol NDC 55154-2145
Misoprostol 200 ug/1 · Tablet · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-2145-0 | 55154214500 | 10 BLISTER PACK in 1 BAG (55154-2145-0) / 1 TABLET in 1 BLISTER PACKMarketed from Dec 10, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076095
- Marketing start
- Listing expires
- Other FDA classes
- Synthetic (Chemical structure)
- Identifiers
- Product ID 55154-2145_dfcc109c-693f-4f2c-a08a-4ca18d681425SPL ID dfcc109c-693f-4f2c-a08a-4ca18d681425
- 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
N455154214500followed by a unit qualifier and the quantityPackage 55154-2145-00. 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.
Other NDCs under ANDA 076095
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. | 43393-023 |
| Misoprostol | Misoprostol 100 ug/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-443 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-444 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-300 |
| Misoprostol | Misoprostol 100 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2455 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | Proficient Rx LP | 82804-037 |
| Misoprostol | Misoprostol 100 ug/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3762 |
| Misoprostol | Misoprostol 100 ug/1 | TabletOral | American Health Packaging | 60687-735 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | American Health Packaging | 60687-746 |