Home NDC 68462-388 MARLISSA
Product NDC 68462-388
11-digit product format 684620388
Labeler code 68462
Product ID 68462-388_c243946a-6bbb-4d5f-8081-1858771fe9de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol
Dosage form KIT
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA091452
Marketing category ANDA
Marketing start 2012-02-29
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 A091452-001 MARLISSA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091452-001 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 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Additional Listing Data#
Finished product Yes
Brand name base MARLISSA
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 238019 Internal RxNorm lookup 748797 Internal RxNorm lookup 748878 Internal RxNorm lookup 1245919 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 68462-388-29 MARLISSA 3 in 1 CARTON KIT 3 14 68462-388-84 MARLISSA 1 in 1 BLISTER PACK KIT 1 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 LEVONORGESTREL ACTIVE INGREDIENT 5W7SIA7YZW MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 LEVONORGESTREL ACTIVE MOIETY 5W7SIA7YZW MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 POLACRILIN POTASSIUM INACTIVE INGREDIENT 0BZ5A00FQU MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-388 MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 13 Current NDC, Legacy NDC, 2 package rows 20240104_9379d99e-c416-4dab-a817-1c110e0d4b93.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 MARLISSA LEVONORGESTREL AND ETHINYL ESTRADIOL Glenmark Pharmaceuticals Inc., USA 9379d99e-c416-4dab-a817-1c110e0d4b93 2026-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091452 application number: ANDA091452 ndc (product): 68462-388
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 68462-388-29 68462038829 3 BLISTER PACK in 1 CARTON (68462-388-29) / 1 KIT in 1 BLISTER PACK (68462-388-84) 3 blister pack 2012-02-29 0000-00-00 No No Current 68462-388-84 68462038884 1 in 1 BLISTER PACK Historical