estrogens, conjugated

Product NDC
50742-388
11-digit product format
507420388
Labeler code
50742
Product ID
50742-388_420e847b-9359-4557-be3e-8b0c8cb3203b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estrogens, conjugated
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA214025
Marketing category
ANDA
Marketing start
2025-10-16
Substance
ESTROGENS, CONJUGATED
Active strength
.45 mg/1
Pharmacologic classes
Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
estrogens, conjugated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTROGENS, CONJUGATED.45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIU5QR144QX
Rxcui197660, 310197, 403849

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
d95be220-b30e-4165-a12d-f83825b0efb1Product name120160111
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
2e1ce74f-4938-37b4-e2b4-cfd7971b45eaProduct name120140508
d90784c3-64a2-2f23-9acd-d948d25bf235Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-388-01estrogens, conjugated100 in 1 BOTTLETABLET, FILM COATED1001
50742-388-10estrogens, conjugated1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-388-01EA - Each50742-388838d4e6f-0b88-42d1-8c3e-2c062145971b12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197660estrogens, conjugated 0.3 MG Oral TabletPSNb17eca23-f387-4243-a76a-bcf6b88aeef91
403849estrogens, conjugated 0.45 MG Oral TabletPSNb17eca23-f387-4243-a76a-bcf6b88aeef91
310197estrogens, conjugated 0.625 MG Oral TabletPSNb17eca23-f387-4243-a76a-bcf6b88aeef91
197660estrogens, conjugated (USP) 0.3 MG Oral TabletSCDb17eca23-f387-4243-a76a-bcf6b88aeef91
403849estrogens, conjugated (USP) 0.45 MG Oral TabletSCDb17eca23-f387-4243-a76a-bcf6b88aeef91
310197estrogens, conjugated (USP) 0.625 MG Oral TabletSCDb17eca23-f387-4243-a76a-bcf6b88aeef91
310197estrogens, conjugated (USP) 625 MCG Oral TabletSYb17eca23-f387-4243-a76a-bcf6b88aeef91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50742-388-0150742038801100 TABLET, FILM COATED in 1 BOTTLE (50742-388-01) 2025-10-16NoNoHistorical
50742-388-10507420388101000 TABLET, FILM COATED in 1 BOTTLE (50742-388-10) 2025-10-16NoNoHistorical