Misoprostol

Product NDC
43063-707
11-digit product format
430630707
Labeler code
43063
Product ID
43063-707_dc14e690-3f40-fa8c-e053-2a95a90ad3d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091667
Marketing category
ANDA
Marketing start
2012-07-25
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-707-02EA - Each43063-7070868a8a8-e1b4-4b98-b236-f66073d1f7fe12016-10-06
43063-707-04EA - Each43063-707b31cca7c-f97f-4549-a4d0-a75182887c3512016-10-06
43063-707-06EA - Each43063-7074e6a718e-14b1-4c49-8c64-6885aa3639dd12016-10-06
43063-707-08EA - Each43063-70760331cca-6153-4741-9c82-57f66f2061d612016-10-06
43063-707-13EA - Each43063-7075c794c73-71bf-4ab7-829e-f2eb6c19d8d512016-10-06
43063-707-20EA - Each43063-7073ebc25b7-e1a4-4f6a-bffa-15acb87d087412017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-707MISOPROSTOL TABLET [PD-RX PHARMACEUTICALS, INC.]15Legacy NDC20241016_a2925ca4-fefb-4a4b-a262-dc8559b50b91.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-707-02430630707022 TABLET in 1 BOTTLE, PLASTIC (43063-707-02) 2 tablet2016-09-200000-00-00NoNoCurrent
43063-707-04430630707044 TABLET in 1 BOTTLE, PLASTIC (43063-707-04) 4 tablet2016-09-200000-00-00NoNoCurrent
43063-707-06430630707066 TABLET in 1 BOTTLE, PLASTIC (43063-707-06) 6 tablet2016-09-200000-00-00NoNoCurrent
43063-707-08430630707088 TABLET in 1 BOTTLE, PLASTIC (43063-707-08) 8 tablet2016-09-200000-00-00NoNoCurrent
43063-707-134306307071313 TABLET in 1 BOTTLE, PLASTIC (43063-707-13) 13 tablet2016-09-200000-00-00NoNoCurrent
43063-707-204306307072020 TABLET in 1 BOTTLE, PLASTIC (43063-707-20) 20 tablet2017-05-160000-00-00NoNoCurrent