Prescription drug · ANDA
Misoprostol NDC 43386-161
Misoprostol 200 ug/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-161-01 | 4338601610143386016101 | 100 TABLET in 1 BOTTLE (43386-161-01)Marketed from Jul 25, 2012 | |
| 43386-161-06 | 4338601610643386016106 | 60 TABLET in 1 BOTTLE (43386-161-06)Marketed from Jul 25, 2012 |
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
- Lupin Pharmaceuticals,Inc.NDC labeler code 43386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091667
- Marketing start
- Listing expires
- Other FDA classes
- Synthetic (Chemical structure)
- Identifiers
- Product ID 43386-161_b702aa1b-6c21-e44f-e053-2995a90a16f2SPL ID b702aa1b-6c21-e44f-e053-2995a90a16f2SPL set ID 14f73ae3-7d8d-4d10-b668-8bd5adf8032cRxCUI 311727, 317128UNII 0E43V0BB57UPC 0343386160068
- 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
N443386016101followed by a unit qualifier and the quantityPackage 43386-0161-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND 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 Tablet has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol Tablets should be taken for the duration of NSAID therapy. Misoprostol Tablets has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no…
Excerpt only. Read the full label for complete information.
About NDC 43386-161
- What is NDC 43386-161?
- 43386-161 is the product NDC for Misoprostol, Misoprostol 200 ug/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Misoprostol.
- What is the active ingredient?
- Misoprostol.
- Who is the labeler?
- Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Misoprostol?
- 22 other product NDCs are listed under this name. See all Misoprostol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Misoprostol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | Cardinal Health 107, LLC | 55154-2145 | 55154-2145-00 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | AvPAK | 50268-555 | 50268-0555-60 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | GenBioPro, Inc. | 43393-024 | 43393-0024-04 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | GenBioPro, Inc. | 43393-200 | 43393-0200-4843393-0200-60 |
| Misoprostol | Misoprostol 100 ug/1 | TabletOral | American Health Packaging | 60687-735 | 60687-0735-01 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | American Health Packaging | 60687-746 | 60687-0746-01 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | GenBioPro, Inc. | 43393-023 | 43393-0023-04 |
| Misoprostol | Misoprostol 100 ug/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3762 | 68071-3762-0368071-3762-09 |
| Misoprostol | Misoprostol 100 ug/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-443 | 70954-0443-1070954-0443-20 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-444 | 70954-0444-1070954-0444-20 |
Other NDCs under ANDA 091667
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 100 ug/1 | TabletOral | Novel Laboratories, Inc. | 40032-160 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | Novel Laboratories, Inc. | 40032-161 |
| Misoprostol | Misoprostol 100 ug/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-160 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | PharmPak, Inc. | 54348-148 |
| Misoprostol | Misoprostol 200 ug/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4843 |