Home NDC 59746-764-42 Drospirenone and Ethinyl Estradiol
Product NDC 59746-764
Requested package NDC 59746-764-42
11-digit product format 597460764
Labeler code 59746
Product ID 59746-764_112b5b5c-0106-4f69-a4d7-5319fcc94563
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Drospirenone and ethinyl estradiol
Dosage form KIT
Labeler Jubilant Cadista Pharmaceuticals Inc
Application ANDA210017
Marketing category ANDA
Marketing start 2018-12-31
Marketing end 2021-06-30
Active strength 0
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210017-001 DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET / ORAL-28 2018-09-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A210017-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.03MG TABLET / ORAL-28 2018-09-10 a50c72e98297…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59746-764-42 59746076442 1 BLISTER PACK in 1 PACKAGE (59746-764-42) > 1 KIT in 1 BLISTER PACK 1 blister pack 2018-12-31 2021-06-30 No No Current