FDA.reportPublic FDA data

Drospirenone and Ethinyl Estradiol

Product NDC
59746-763
Requested package NDC
59746-763-43
11-digit product format
597460763
Labeler code
59746
Product ID
59746-763_4219f41b-ed0d-4b19-86ee-5a5470b4d5b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Drospirenone and ethinyl estradiol
Dosage form
KIT
Labeler
Jubilant Cadista Pharmaceuticals Inc
Application
ANDA209423
Marketing category
ANDA
Marketing start
2018-11-30
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59746-76359746-763-43DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209423-001DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE; ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-763-42EA - Each59746-763aca03642-bc80-4212-b53c-f6891b669e3612019-05-02
59746-763-43EA - Each59746-7631ef8e1fa-5f57-4747-938d-01aaf5592b6112019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-763-43597460763431 BLISTER PACK in 1 PACKAGE (59746-763-43) > 1 KIT in 1 BLISTER PACK1 blister pack2018-11-300000-00-00NoNoCurrent