Home NDC 68462-316 BRIELLYN
Product NDC 68462-316
11-digit product format 684620316
Labeler code 68462
Product ID 68462-316_6eb1e9bd-c526-4036-b9b4-ac88811d76e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone and Ethinyl Estradiol
Dosage form KIT
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA090538
Marketing category ANDA
Marketing start 2011-03-23
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 1 .
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 A090538-001 BRIELLYN ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090538-001 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 · 41 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 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base BRIELLYN
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 1094543 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 68462-316-29 BRIELLYN 3 in 1 CARTON KIT 3 13 68462-316-29 BRIELLYN 1 in 1 BLISTER PACK KIT 1 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 NORETHINDRONE ACTIVE INGREDIENT T18F433X4S BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 NORETHINDRONE ACTIVE MOIETY T18F433X4S BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 POVIDONES INACTIVE INGREDIENT FZ989GH94E BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-316 BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 12 Current NDC, Legacy NDC, 2 package rows 20240508_c0e2c5b4-70ac-4b41-aa71-00e506dbb72f.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 BRIELLYN NORETHINDRONE AND ETHINYL ESTRADIOL Glenmark Pharmaceuticals Inc., USA c0e2c5b4-70ac-4b41-aa71-00e506dbb72f 2026-01-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090538 application number: ANDA090538 ndc (product): 68462-316
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 68462-316-29 68462031629 3 BLISTER PACK in 1 CARTON (68462-316-29) / 1 KIT in 1 BLISTER PACK 3 blister pack 2011-03-23 0000-00-00 No No Current