FDA.reportPublic FDA data

Misoprostol

Product NDC
72789-300
11-digit product format
727890300
Labeler code
72789
Product ID
72789-300_4bae2c7c-35bd-ec85-e063-6394a90a5412
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076095
Marketing category
ANDA
Marketing start
2022-04-11
Substance
MISOPROSTOL
Active strength
200 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MISOPROSTOL200 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0E43V0BB57
Rxcui317128

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
72789-300-04Misoprostol4 in 1 BOTTLE, PLASTICTABLET49
72789-300-08Misoprostol8 in 1 BOTTLE, PLASTICTABLET89
72789-300-20Misoprostol20 in 1 BOTTLE, PLASTICTABLET209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-300-04EA - Each72789-300b4763d75-ab65-4d60-a03e-6ce288aca8f012023-03-13
72789-300-08EA - Each72789-3004d9d59ba-f7d6-46d6-af93-23aa4912754f12023-03-13
72789-300-20EA - Each72789-3005fa58f04-957a-4b15-abf1-56924f26583612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-300MISOPROSTOL TABLET [PD-RX PHARMACEUTICALS, INC.]7Current NDC, 3 package rows20240426_51b0bac5-19e3-4547-ba1f-01494fda7687.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317128miSOPROStol 200 MCG Oral TabletPSN51b0bac5-19e3-4547-ba1f-01494fda76879
317128misoprostol 0.2 MG Oral TabletSCD51b0bac5-19e3-4547-ba1f-01494fda76879
317128misoprostol 200 MCG Oral TabletSY51b0bac5-19e3-4547-ba1f-01494fda76879

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-300-04727890300044 TABLET in 1 BOTTLE, PLASTIC (72789-300-04) 4 tablet2023-02-16NoNoCurrent
72789-300-08727890300088 TABLET in 1 BOTTLE, PLASTIC (72789-300-08) 8 tablet2023-02-16NoNoCurrent
72789-300-207278903002020 TABLET in 1 BOTTLE, PLASTIC (72789-300-20) 20 tablet2023-03-08NoNoCurrent