Home NDC 68462-637-29 Levonorgestrel and Ethinyl Estradiol
Product NDC 68462-637
Requested package NDC 68462-637-29
11-digit product format 684620637
Labeler code 68462
Product ID 68462-637_ed921f2c-7961-477a-bbac-2e666d32e3ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA202791
Marketing category ANDA
Marketing start 2015-04-09
Substance LEVONORGESTREL; ETHINYL ESTRADIOL
Active strength 90; 20 ug/1; ug/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [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 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202791-001 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 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202791-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB 2015-04-09 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 Levonorgestrel and Ethinyl Estradiol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVONORGESTREL 90 ug/1 ETHINYL ESTRADIOL 20 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5W7SIA7YZW 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 722152 Internal RxNorm lookup 751553 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 68462-637-29 Levonorgestrel and Ethinyl Estradiol 3 in 1 CARTON TABLET 3 10 68462-637-84 Levonorgestrel and Ethinyl Estradiol 1 in 1 POUCH TABLET 1 10 68462-637-84 Levonorgestrel and Ethinyl Estradiol 28 in 1 BLISTER PACK TABLET 28 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 LEVONORGESTREL ACTIVE INGREDIENT 5W7SIA7YZW LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 LEVONORGESTREL ACTIVE MOIETY 5W7SIA7YZW LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 POLACRILIN POTASSIUM INACTIVE INGREDIENT 0BZ5A00FQU LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-637 LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 9 Current NDC, Legacy NDC, 3 package rows 20240104_44fbc5ae-5682-471f-a12a-955e8b4d233a.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 68462-637-29 68462063729 3 POUCH in 1 CARTON (68462-637-29) / 1 BLISTER PACK in 1 POUCH (68462-637-84) / 28 TABLET in 1 BLISTER PACK 3 pouch 2015-04-09 0000-00-00 No No Current