Home NDC 59651-030 Zumandimine
Product NDC 59651-030
11-digit product format 596510030
Labeler code 59651
Product ID 59651-030_7cec3990-8d5f-4585-8bbc-fe2556cf69f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Drospirenone and Ethinyl Estradiol
Dosage form KIT
Labeler Aurobindo Pharma Limited
Application ANDA209407
Marketing category ANDA
Marketing start 2018-03-26
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A209407-001 ZUMANDIMINE DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209407-001 AB
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209407-001 ZUMANDIMINE 3MG;0.03MG TABLET / ORAL-28 AB 2018-03-26 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zumandimine
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284207 Internal RxNorm lookup 748797 Internal RxNorm lookup 748800 Internal RxNorm lookup 2045196 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-030 ZUMANDIMINE (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED] 10 Current NDC, Legacy NDC, 8 package rows 20231102_192ad3b0-9ef2-409d-a851-77712202c45a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zumandimine DROSPIRENONE AND ETHINYL ESTRADIOL Aurobindo Pharma Limited 192ad3b0-9ef2-409d-a851-77712202c45a 2023-10-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209407 application number: ANDA209407 ndc (product): 59651-030
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59651-030-28 59651003028 1 BLISTER PACK in 1 CARTON (59651-030-28) / 1 KIT in 1 BLISTER PACK 1 blister pack 2018-03-26 0000-00-00 No No Current 59651-030-85 59651003085 3 BLISTER PACK in 1 CARTON (59651-030-85) / 1 KIT in 1 BLISTER PACK 3 blister pack 2018-03-26 0000-00-00 No No Current 59651-030-87 59651003087 1 POUCH in 1 CARTON (59651-030-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 1 pouch 2018-03-26 0000-00-00 No No Current 59651-030-88 59651003088 3 POUCH in 1 CARTON (59651-030-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 3 pouch 2018-03-26 0000-00-00 No No Current