Home NDC 59651-740 Rhuzdah
Product NDC 59651-740
11-digit product format 596510740
Labeler code 59651
Product ID 59651-740_450fc33f-0716-47fe-b810-f10f372ab98a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norethindrone and ethinyl estradiol tablet
Dosage form KIT
Labeler Aurobindo Pharma Limited
Application ANDA207585
Marketing category ANDA
Marketing start 2022-10-11
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A207585-001 RHUZDAH ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11
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 2026-10-15 13:18:30 2026-09 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 AB 2022-10-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 AB 2022-10-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 AB 2022-10-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 AB 2022-10-11 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207585-001 RHUZDAH 0.035MG;0.4MG TABLET / ORAL-28 2022-10-11 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Rhuzdah
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238015 Internal RxNorm lookup 748797 Internal RxNorm lookup 749736 Internal RxNorm lookup 2624207 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 59651-740 RHUZDAH (NORETHINDRONE AND ETHINYL ESTRADIOL TABLET) KIT [AUROBINDO PHARMA LIMITED] 3 Current NDC, Legacy NDC, 4 package rows 20231124_dea10e78-0e7b-4404-9c3a-ed2447a1788b.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 Rhuzdah NORETHINDRONE AND ETHINYL ESTRADIOL TABLET Aurobindo Pharma Limited dea10e78-0e7b-4404-9c3a-ed2447a1788b 2023-11-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207585 application number: ANDA207585 ndc (product): 59651-740
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 59651-740-88 59651074088 3 POUCH in 1 CARTON (59651-740-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 3 pouch 2022-10-11 0000-00-00 No No Current 59651-740-92 59651074092 6 POUCH in 1 CARTON (59651-740-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 6 pouch 2022-10-11 0000-00-00 No No Current