Misoprostol NDC 43386-161

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-161Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0161Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43386-161-01	43386016101	100 TABLET in 1 BOTTLE (43386-161-01)Marketed from Jul 25, 2012
43386-161-06	43386016106	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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091667
Marketing start: Jul 25, 2012
Listing expires: Dec 31, 2026
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

N443386016101 followed by a unit qualifier and the quantity

Package 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 Dec 21, 2020. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091667

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091667
Product	Strength	Form · route	Labeler	Product NDC
Misoprostol	Misoprostol 200 ug/1	TabletOral	Novel Laboratories, Inc.	40032-161
Misoprostol	Misoprostol 100 ug/1	TabletOral	Novel Laboratories, Inc.	40032-160
Misoprostol	Misoprostol 200 ug/1	TabletOral	PharmPak, Inc.	54348-148
Misoprostol	Misoprostol 200 ug/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4843
Misoprostol	Misoprostol 100 ug/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-160