Home NDC 68462-132 Norethindrone Acetate and Ethinyl Estradiol
Product NDC 68462-132
11-digit product format 684620132
Labeler code 68462
Product ID 68462-132_0f4e690d-1b9a-4c51-ac0a-8aa783056a00
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone Acetate and Ethinyl Estradiol
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA206969
Marketing category ANDA
Marketing start 2016-01-20
Substance NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
Active strength 1; .02 mg/1; mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
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 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206969-001 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 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206969-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.02MG;1MG TABLET / ORAL-21 AB 2016-01-20 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 Norethindrone Acetate and Ethinyl Estradiol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORETHINDRONE ACETATE 1 mg/1 ETHINYL ESTRADIOL .02 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1358762 Internal RxNorm lookup 1358776 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 68462-132-79 Norethindrone Acetate and Ethinyl Estradiol 1 in 1 POUCH TABLET 1 7 68462-132-79 Norethindrone Acetate and Ethinyl Estradiol 21 in 1 BLISTER PACK TABLET 21 7 68462-132-81 Norethindrone Acetate and Ethinyl Estradiol 3 in 1 CARTON TABLET 3 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-132 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 Current NDC, Legacy NDC, 3 package rows 20240628_5a44f7a2-45f1-4d28-b9fb-61d9f2456422.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 · 2 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 68462-132-79 68462013279 1 in 1 POUCH Historical 68462-132-81 68462013281 3 POUCH in 1 CARTON (68462-132-81) / 1 BLISTER PACK in 1 POUCH (68462-132-79) / 21 TABLET in 1 BLISTER PACK 3 pouch 2016-01-20 0000-00-00 No No Current