Home NDC 68462-731 Hailey 24 Fe
Product NDC 68462-731
11-digit product format 684620731
Labeler code 68462
Product ID 68462-731_12f7a9d2-4627-40c2-987f-202a9aad27de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Dosage form KIT
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA204847
Marketing category ANDA
Marketing start 2017-11-17
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 43 .
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 A204847-001 HAILEY 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204847-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB 2017-11-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204847-001 HAILEY 24 FE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204847-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG TABLET / ORAL AB RS 2017-11-17 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 Hailey 24 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 259176 Internal RxNorm lookup 1358762 Internal RxNorm lookup 1359117 Internal RxNorm lookup 1989507 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-731-29 Hailey 24 Fe 3 in 1 CARTON KIT 3 11 68462-731-84 Hailey 24 Fe 1 in 1 BLISTER PACK KIT 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-731 HAILEY 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [GLENMARK PHARMACEUTICALS INC., USA] 10 Current NDC, Legacy NDC, 2 package rows 20230215_ab399c1c-5613-4e7d-88f7-ec41533d4da3.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 Hailey 24 Fe NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE Glenmark Pharmaceuticals Inc., USA ab399c1c-5613-4e7d-88f7-ec41533d4da3 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204847 application number: ANDA204847 ndc (product): 68462-731
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 68462-731-29 68462073129 3 BLISTER PACK in 1 CARTON (68462-731-29) / 1 KIT in 1 BLISTER PACK (68462-731-84) 3 blister pack 2017-11-17 0000-00-00 No No Current 68462-731-84 68462073184 1 in 1 BLISTER PACK Historical