Estradiol

Product NDC
0378-1458
11-digit product format
003781458
Labeler code
0378
Product ID
0378-1458_51d263ac-6b9e-4bd4-8d67-5fa164908755
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA040326
Marketing category
ANDA
Marketing start
1999-06-17
Marketing end
2021-09-30
Substance
ESTRADIOL
Active strength
2 mg/1
Pharmacologic classes
Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1458-01EA - Each0378-145843f73c98-1af1-43a4-aa4d-5e0f4f3c795412012-07-24
0378-1458-05EA - Each0378-14582b824561-7aee-41e8-aad9-523b2215ce5012012-07-24
0378-1458-77EA - Each0378-145815ff6bd0-528c-4696-9a91-408573f2a5f712012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1458-0100378145801100 TABLET in 1 BOTTLE, PLASTIC (0378-1458-01) 100 tablet1999-06-170000-00-00NoNoCurrent
0378-1458-0500378145805500 TABLET in 1 BOTTLE, PLASTIC (0378-1458-05) 500 tablet1999-06-170000-00-00NoNoCurrent
0378-1458-770037814587790 TABLET in 1 BOTTLE, PLASTIC (0378-1458-77) 90 tablet1999-06-170000-00-00NoNoCurrent