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 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 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.
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 2026-08-01 22:54:32 2026-06 A091452-001 MARLISSA 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-02-29 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A091452-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
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