Misoprostol NDC 43393-200

NDC codes

FDA NDC Directory

Product NDC (as listed)43393-200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43393-0200Add 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
43393-200-48	43393020048	12 BLISTER PACK in 1 CARTON (43393-200-48) / 4 TABLET in 1 BLISTER PACK (43393-200-04)Marketed from Sep 30, 2024
43393-200-60	43393020060	60 TABLET in 1 BOTTLE (43393-200-60)Marketed from Sep 30, 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: GenBioPro, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210201
Marketing start: Sep 30, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Synthetic (Chemical structure)
Identifiers: Product ID 43393-200_53976d1e-81b7-3b03-e063-6394a90a0e4eSPL ID 53976d1e-81b7-3b03-e063-6394a90a0e4eSPL set ID 21e20753-4a67-ce4e-e063-6394a90aa598RxCUI 317128UNII 0E43V0BB57UPC 0343393200047
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

N443393020048 followed by a unit qualifier and the quantity

Package 43393-0200-48. 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 Jun 6, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Misoprostol tablets are 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, compa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210201

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

FDA NDC Directory listings under ANDA 210201
Product	Strength	Form · route	Labeler	Product NDC
Misoprostol	Misoprostol 200 ug/1	TabletOral	GenBioPro, Inc.	43393-024
Misoprostol	Misoprostol 200 ug/1	TabletOral	AvPAK	50268-555