Home NDC 75834-130 Norethindrone Acetate and Ethinyl Estradiol
Product NDC 75834-130
11-digit product format 758340130
Labeler code 75834
Product ID 75834-130_4ffa902e-2cf8-4160-ba1e-f27e48b8e502
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone Acetate and Ethinyl Estradiol
Dosage form TABLET
Route ORAL
Labeler Nivagen Pharmaceuticals, Inc.
Application ANDA203435
Marketing category ANDA
Marketing start 2016-11-25
Substance ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active strength .005; 1 mg/1; mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203435-001 LERIBANE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 A203435-002 LERIBANE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Norethindrone Acetate and Ethinyl Estradiol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORETHINDRONE ACETATE .005 mg/1 ETHINYL ESTRADIOL 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9S44LIC7OJ Internal UNII lookup 423D2T571U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090992 Internal RxNorm lookup 1251323 Internal RxNorm lookup 1251334 Internal RxNorm lookup 1251336 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 75834-130-29 Norethindrone Acetate and Ethinyl Estradiol 3 in 1 CARTON TABLET 3 5 75834-130-84 Norethindrone Acetate and Ethinyl Estradiol 28 in 1 BLISTER PACK TABLET 28 5 75834-130-90 Norethindrone Acetate and Ethinyl Estradiol 90 in 1 BOTTLE TABLET 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75834-130 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [NIVAGEN PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 3 package rows 20231125_2c2a37e1-adaf-4947-abb1-736bfa58bf98.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.
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 75834-130-29 75834013029 3 BLISTER PACK in 1 CARTON (75834-130-29) / 28 TABLET in 1 BLISTER PACK (75834-130-84) 3 blister pack 2016-11-25 0000-00-00 No No Current 75834-130-84 75834013084 28 in 1 BLISTER PACK Historical 75834-130-90 75834013090 90 TABLET in 1 BOTTLE (75834-130-90) 90 tablet 2016-11-25 0000-00-00 No No Current