Prescription drug · NDA
Cytotec (Misoprostol) NDC 0025-1451
Misoprostol 100 ug/1 · Tablet · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0025-1451-60 | 0002514516000025145160 | 60 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1451-60)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 — 100 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0025
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019268
- Marketing start
- Listing expires
- Other FDA classes
- Synthetic (Chemical structure)
- Identifiers
- Product ID 0025-1451_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
N400025145160followed by a unit qualifier and the quantityPackage 00025-1451-60. 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 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.
About NDC 0025-1451
- What is NDC 0025-1451?
- 0025-1451 is the product NDC for Cytotec (misoprostol), Misoprostol 100 ug/1 tablet, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cytotec (Misoprostol).
- What is the active ingredient?
- Misoprostol.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0025. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cytotec?
- 1 other product NDC are listed under this name. See all Cytotec NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cytotec products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cytotecmisoprostol | Misoprostol 200 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 0025-1461 | 00025-1461-3100025-1461-60 |
Other NDCs under NDA 019268
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 |
|---|---|---|---|---|
| Cytotecmisoprostol | Misoprostol 200 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 0025-1461 |
| 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 |