Prempro

Product NDC
69189-1107
11-digit product format
691891107
Labeler code
69189
Product ID
69189-1107_77384e53-ea65-401b-bcd2-21a32efc889a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA020527
Marketing category
NDA
Marketing start
2016-01-28
Marketing end
0000-00-00
Substance
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Active strength
1 mg/1; mg/1
Pharmacologic classes
Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS],Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
d95be220-b30e-4165-a12d-f83825b0efb1Product name120160111
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
2e1ce74f-4938-37b4-e2b4-cfd7971b45eaProduct name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
d90784c3-64a2-2f23-9acd-d948d25bf235Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-1107-1Prempro1 in 1 DOSE PACKTABLET, SUGAR COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-1107PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170412_62551977-a89a-4a97-bdf1-ef74868d3c1a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-1107-1691891107011 in 1 DOSE PACKHistorical