Cytotec (misoprostol) NDC 0025-1461

NDC codes

FDA NDC Directory

Product NDC (as listed)0025-1461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00025-1461Add 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
0025-1461-31	00025146131	100 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-31)Marketed from Dec 27, 1986
0025-1461-60	00025146160	60 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-60)Marketed from Dec 27, 1986

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Cytotec
Generic name (nonproprietary): misoprostol
Active ingredients: Misoprostol — 200 ug/1
Dosage form: Tablet
Route: Oral
Labeler: Pfizer Laboratories Div Pfizer Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019268
Marketing start: Dec 27, 1986
Listing expires: Dec 31, 2027
Other FDA classes: Synthetic (Chemical structure)
Identifiers: Product ID 0025-1461_35b84693-8a34-4008-831d-cd1df3724343SPL ID 35b84693-8a34-4008-831d-cd1df3724343SPL set ID 4ab12da7-5731-4e06-bf1c-bc3f2e711f12RxCUI 104098, 209177, 311727, 317128UNII 0E43V0BB57UPC 0300251461606
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

N400025146131 followed by a unit qualifier and the quantity

Package 00025-1461-31. 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 4, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cytotec (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. Cytotec has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Cytotec should be taken for the duration of NSAID therapy. Cytotec 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019268

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

FDA NDC Directory listings under NDA 019268
Product	Strength	Form · route	Labeler	Product NDC
misoprostol	Misoprostol 100 ug/1	TabletOral	Mylan Pharmaceuticals Inc.	59762-5007
misoprostol	Misoprostol 200 ug/1	TabletOral	Mylan Pharmaceuticals Inc.	59762-5008
misoprostol	Misoprostol 200 ug/1	TabletOral	Redpharm Drug	67296-1936
misoprostol	Misoprostol 100 ug/1	TabletOral	Bryant Ranch Prepack	71335-9631
Cytotecmisoprostol	Misoprostol 100 ug/1	TabletOral	Pfizer Laboratories Div Pfizer Inc	0025-1451