Home NDC 65862-926 Nexesta Fe
Product NDC 65862-926
11-digit product format 658620926
Labeler code 65862
Product ID 65862-926_c442d603-f61f-4f9e-8776-15d764842c27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norethindrone and ethinyl estradiol and ferrous fumarate
Dosage form KIT
Labeler Aurobindo Pharma Limited
Application ANDA207535
Marketing category ANDA
Marketing start 2017-02-02
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 A207535-001 NEXESTA FE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207535-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2017-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207535-001 NEXESTA FE 0.035MG;0.4MG TABLET / ORAL AB 2017-02-02 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A207535-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207535-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207535-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207535-001 AB 1 a50c72e98297…
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 Nexesta Fe
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 433718 Internal RxNorm lookup 1095223 Internal RxNorm lookup 1095224 Internal RxNorm lookup 1869047 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 65862-926 NEXESTA FE (NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [AUROBINDO PHARMA LIMITED] 6 Current NDC, Legacy NDC, 8 package rows 20211212_6eb8f7b6-4b8e-4bad-800a-b2f3b36c3413.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 Nexesta Fe NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Aurobindo Pharma Limited 6eb8f7b6-4b8e-4bad-800a-b2f3b36c3413 2021-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207535 application number: ANDA207535 ndc (product): 65862-926
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 65862-926-58 65862092658 5 POUCH in 1 CARTON (65862-926-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 5 pouch 2017-02-02 0000-00-00 No No Current 65862-926-87 65862092687 1 POUCH in 1 CARTON (65862-926-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 1 pouch 2017-02-02 0000-00-00 No No Current 65862-926-88 65862092688 3 POUCH in 1 CARTON (65862-926-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 3 pouch 2017-02-02 0000-00-00 No No Current 65862-926-97 65862092697 72 POUCH in 1 CARTON (65862-926-97) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 72 pouch 2017-02-02 0000-00-00 No No Current