Misoprostol

Product NDC
68071-2904
11-digit product format
680712904
Labeler code
68071
Product ID
68071-2904_f05b47da-657f-6cf0-e053-2a95a90a02bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076095
Marketing category
ANDA
Marketing start
2022-04-11
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
2023-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2904-42025-01-30C16284748780-12cef2736-6c35-d83d-e063-dadaa90ab31fMisoprostol Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2904-4Misoprostol4 in 1 BOTTLETABLET41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2904MISOPROSTOL TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20221223_f05b4562-4301-81dc-e053-2995a90a6b6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317128miSOPROStol 200 MCG Oral TabletPSNf05b4562-4301-81dc-e053-2995a90a6b6f1
317128misoprostol 0.2 MG Oral TabletSCDf05b4562-4301-81dc-e053-2995a90a6b6f1
317128misoprostol 200 MCG Oral TabletSYf05b4562-4301-81dc-e053-2995a90a6b6f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2904-4680712904044 TABLET in 1 BOTTLE (68071-2904-4) 4 tablet2022-12-210000-00-00NoNoCurrent