Prescription drug · ANDA
Misoprostol NDC 70954-443
Misoprostol 100 ug/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-443-10 | 70954044310 | 60 TABLET in 1 BOTTLE (70954-443-10)Marketed from Apr 11, 2022 | |
| 70954-443-20 | 70954044320 | 120 TABLET in 1 BOTTLE (70954-443-20)Marketed from Apr 11, 2022 |
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 — 100 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- 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 70954-443_f271c446-37dd-4a1f-8664-c8ccea4ab1ceSPL ID f271c446-37dd-4a1f-8664-c8ccea4ab1ceSPL set ID 21386aa1-dc51-41c9-8872-dec4c71ebb46RxCUI 311727, 317128UNII 0E43V0BB57UPC 0370954444107, 0370954444206, 0370954443100, 0370954443209
- 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
N470954044310followed by a unit qualifier and the quantityPackage 70954-0443-10. 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)
INDICATIONS & USAGE Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to plac…
Excerpt only. Read the full label for complete information.
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 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 | Cardinal Health 107, LLC | 55154-2145 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | American Health Packaging | 60687-746 |