FDA.reportPublic FDA data

Cytotec

Product NDC
0025-1451
11-digit product format
000251451
Labeler code
0025
Product ID
0025-1451_253d5240-18d7-4f06-8314-a5632648cd47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA019268
Marketing category
NDA
Marketing start
1986-12-27
Substance
MISOPROSTOL
Active strength
100 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cytotec
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MISOPROSTOL100 ug/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9Product name320231221
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0025-1451-34Cytotec100 in 1 CARTONTABLET10021
0025-1451-34Cytotec1 in 1 BLISTER PACKTABLET121
0025-1451-60Cytotec60 in 1 BOTTLE, UNIT-DOSETABLET6021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0025-1451-20EA - Each0025-145168ec755d-3886-4f22-a560-86527e6cf6c112012-07-24
0025-1451-34EA - Each0025-14510706fdf8-89e3-454b-a9df-f9de4d9d5f8412012-07-24
0025-1451-60EA - Each0025-1451481d9884-1a5b-4d01-80e4-058d3ffa073e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
MISOPROSTOLACTIVE MOIETY0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYTOTEC (MISOPROSTOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCYTOTEC (MISOPROSTOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCYTOTEC (MISOPROSTOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0025-1451CYTOTEC (MISOPROSTOL) TABLET [PFIZER LABORATORIES DIV PFIZER INC]19Current NDC, Legacy NDC, 3 package rows20250221_4ab12da7-5731-4e06-bf1c-bc3f2e711f12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209177Cytotec 100 MCG Oral TabletPSN4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
104098Cytotec 200 MCG Oral TabletPSN4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
311727miSOPROStol 100 MCG Oral TabletPSN4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
317128miSOPROStol 200 MCG Oral TabletPSN4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
209177misoprostol 0.1 MG Oral Tablet [Cytotec]SBD4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
104098misoprostol 0.2 MG Oral Tablet [Cytotec]SBD4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
311727misoprostol 0.1 MG Oral TabletSCD4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
317128misoprostol 0.2 MG Oral TabletSCD4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
104098Cyotec 200 MCG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
209177Cytotec 0.1 MG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
104098Cytotec 0.2 MG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
209177Cytotec 100 MCG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
311727misoprostol 100 MCG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
317128misoprostol 200 MCG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
209177Cytotec 100 MCG Oral TabletPSN74ae4775-8190-4bab-93d0-0f209023f9731
311727miSOPROStol 100 MCG Oral TabletPSN74ae4775-8190-4bab-93d0-0f209023f9731
209177misoprostol 0.1 MG Oral Tablet [Cytotec]SBD74ae4775-8190-4bab-93d0-0f209023f9731
311727misoprostol 0.1 MG Oral TabletSCD74ae4775-8190-4bab-93d0-0f209023f9731
209177Cytotec 0.1 MG Oral TabletSY74ae4775-8190-4bab-93d0-0f209023f9731
209177Cytotec 100 MCG Oral TabletSY74ae4775-8190-4bab-93d0-0f209023f9731
311727misoprostol 100 MCG Oral TabletSY74ae4775-8190-4bab-93d0-0f209023f9731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0025-1451-3400025145134100 BLISTER PACK in 1 CARTON (0025-1451-34) / 1 TABLET in 1 BLISTER PACK100 blister pack1986-12-270000-00-00NoNoCurrent
0025-1451-600002514516060 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1451-60) 60 tablet1986-12-270000-00-00NoNoCurrent