Levonorgestrel and Ethinyl Estradiol

Product NDC
0591-0295
11-digit product format
005910295
Labeler code
0591
Product ID
0591-0295_39a50ad7-de55-40b3-8105-b63d36bd2411
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levonorgestrel and Ethinyl Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA079218
Marketing category
ANDA
Marketing start
2020-04-01
Marketing end
0000-00-00
Substance
LEVONORGESTREL; ETHINYL ESTRADIOL
Active strength
90 ug/1; ug/1
Pharmacologic classes
Estrogen Receptor Agonists [MoA],Estrogen [EPC],Inhibit Ovum Fertilization [PE],Progesterone Congeners [CS],Progesterone Congeners [CS],Progestin [EPC],Progestin-containing Intrauterine Device [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-0295-28005910295281 BLISTER PACK in 1 CARTON (0591-0295-28) > 28 TABLET in 1 BLISTER PACK1 blister pack2020-04-010000-00-00NoNoCurrent