FDA.reportPublic FDA data

Misoprostol

Product NDC
82804-037
11-digit product format
828040037
Labeler code
82804
Product ID
82804-037_85410e16-d164-4666-9539-778e2b4dd138
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Misoprostol
Listing expiration
2026-12-31

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
82804-037-10Misoprostol10 in 1 BOTTLETABLET101
82804-037-20Misoprostol20 in 1 BOTTLETABLET201
82804-037-30Misoprostol30 in 1 BOTTLETABLET301
82804-037-60Misoprostol60 in 1 BOTTLETABLET601
82804-037-90Misoprostol90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-037-10EA - Each82804-03780eec1b4-52cf-4f81-a77c-f6a9fab22a8212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-037MISOPROSTOL TABLET [PROFICIENT RX LP]1Current NDC, 5 package rows20231111_85410e16-d164-4666-9539-778e2b4dd138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317128miSOPROStol 200 MCG Oral TabletPSN85410e16-d164-4666-9539-778e2b4dd1381
317128misoprostol 0.2 MG Oral TabletSCD85410e16-d164-4666-9539-778e2b4dd1381
317128misoprostol 200 MCG Oral TabletSY85410e16-d164-4666-9539-778e2b4dd1381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-037-108280400371010 TABLET in 1 BOTTLE (82804-037-10) 10 tablet2023-11-07NoNoCurrent
82804-037-208280400372020 TABLET in 1 BOTTLE (82804-037-20) 20 tablet2023-11-07NoNoCurrent
82804-037-308280400373030 TABLET in 1 BOTTLE (82804-037-30) 30 tablet2023-11-07NoNoCurrent
82804-037-608280400376060 TABLET in 1 BOTTLE (82804-037-60) 60 tablet2023-11-07NoNoCurrent
82804-037-908280400379090 TABLET in 1 BOTTLE (82804-037-90) 90 tablet2023-11-07NoNoCurrent