NDC 0025-1461

Cytotec

Misoprostol

Cytotec is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by G.d. Searle Llc Division Of Pfizer Inc. The primary component is Misoprostol.

• Product ID: 0025-1461_05aeff6d-88d9-4fab-92b6-b91429d49838
• NDC: 0025-1461
• Product Type: Human Prescription Drug
• Proprietary Name: Cytotec
• Generic Name: Misoprostol
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1986-12-27
• Marketing Category: NDA / NDA
• Application Number: NDA019268
• Labeler Name: G.D. Searle LLC Division of Pfizer Inc
• Substance Name: MISOPROSTOL
• Active Ingredient Strength: 200 ug/1
• Pharm Classes: Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0025-1461-31

100 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-31)

• Marketing Start Date: 1986-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0025-1461-60 [00025146160]

Cytotec TABLET

• Marketing Category: NDA
• Application Number: NDA019268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1986-12-27

NDC 0025-1461-31 [00025146131]

Cytotec TABLET

• Marketing Category: NDA
• Application Number: NDA019268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1986-12-27

NDC 0025-1461-34 [00025146134]

Cytotec TABLET

• Marketing Category: NDA
• Application Number: NDA019268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1986-12-27

Drug Details

Active Ingredients

Ingredient	Strength
MISOPROSTOL	200 ug/1

OpenFDA Data

• SPL SET ID: 4ab12da7-5731-4e06-bf1c-bc3f2e711f12
• Manufacturer:
  • G.D. Searle LLC Division of Pfizer Inc
• UNII:
  • 0E43V0BB57
• RxNorm Concept Unique ID - RxCUI:
  • 317128
  • 104098
  • 311727
  • 209177

Pharmacological Class

• Prostaglandin E1 Analog [EPC]
• Prostaglandins E
• Synthetic [CS]

NDC Crossover Matching brand name "Cytotec" or generic name "Misoprostol"

NDC	Brand Name	Generic Name
0025-1451	Cytotec	misoprostol
0025-1461	Cytotec	misoprostol
12634-933	CYTOTEC	MISOPROSTOL
55289-248	Cytotec	Cytotec
0179-0218	Misoprostol	Misoprostol
0904-6806	Misoprostol	Misoprostol
0904-6807	Misoprostol	Misoprostol
10135-745	Misoprostol	Misoprostol
10135-746	Misoprostol	Misoprostol
12634-502	misoprostol	MISOPROSTOL
33261-076	Misoprostol	Misoprostol
33261-754	Misoprostol	Misoprostol
40032-160	Misoprostol	Misoprostol
40032-161	Misoprostol	Misoprostol
42571-253	MISOPROSTOL	Misoprostol
42571-254	MISOPROSTOL	Misoprostol
43063-707	Misoprostol	Misoprostol
43386-160	Misoprostol	Misoprostol
43386-161	Misoprostol	Misoprostol
43393-020	misoprostol	MISOPROSTOL
43393-022	Misoprostol	Misoprostol
43393-023	Misoprostol	Misoprostol
43393-203	Misoprostol	Misoprostol
50436-3172	Misoprostol	Misoprostol
52959-692	misoprostol	misoprostol