Misoprostol

Product NDC
63704-008
11-digit product format
637040008
Labeler code
63704
Product ID
63704-008_bfad3255-81e7-4716-bf48-f20d897b16a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Pharmacist Pharmaceutical, LLC
Application
ANDA091667
Marketing category
ANDA
Marketing start
2013-04-12
Marketing end
0000-00-00
Substance
MISOPROSTOL
Active strength
200 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63704-008-01EA - Each63704-008e02aa0f3-a03a-415b-bd21-5a3a7706018912013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MisoprostolACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [PHARMACIST PHARMACEUTICAL, LLC]3
misoprostolACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [PHARMACIST PHARMACEUTICAL, LLC]3
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [PHARMACIST PHARMACEUTICAL, LLC]3
CrospovidoneINACTIVE INGREDIENT68401960MKMISOPROSTOL TABLET [PHARMACIST PHARMACEUTICAL, LLC]3
Hydrogenated Castor OilINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [PHARMACIST PHARMACEUTICAL, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63704-008MISOPROSTOL TABLET [PHARMACIST PHARMACEUTICAL, LLC]4Legacy NDC20181218_26aebc95-bd60-4ded-b99c-63f154c5937a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317128miSOPROStol 200 MCG Oral TabletPSN6801a2df-2ed3-43c8-84d3-6855800589ed4
317128misoprostol 0.2 MG Oral TabletSCD6801a2df-2ed3-43c8-84d3-6855800589ed4
317128misoprostol 200 MCG Oral TabletSY6801a2df-2ed3-43c8-84d3-6855800589ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63704-008-0163704000801100 TABLET in 1 BOTTLE (63704-008-01) 100 tablet2013-04-120000-00-00NoNoCurrent