FDA.reportPublic FDA data

NDC 68462-388-84 - MARLISSA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68462-388
Requested NDC
68462-388-84
Package NDCs from labels
68462-388-84, 68462-388-29
Manufacturer
Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited
Effective date
2026-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MARLISSA - Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-01-29HUMAN PRESCRIPTION DRUG LABEL
MARLISSA ® (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg)Preferreed Pharmaceuticals Inc.2020-07-15HUMAN PRESCRIPTION DRUG LABEL
MARLISSA - A-S Medication SolutionsA-S Medication Solutions2020-02-14HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-388-29MARLISSA3 in 1 CARTONKIT314
68462-388-84MARLISSA1 in 1 BLISTER PACKKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-388MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]13Current NDC, Legacy NDC, 2 package rows20240104_9379d99e-c416-4dab-a817-1c110e0d4b93.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-388-29EA - Each68462-3883c68c281-b9a9-4c91-ad8d-9a03c44d75ab12012-07-24
68462-388-84EA - Each68462-388477743a5-ff29-4e92-9371-3a28256aa80a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
TALCINACTIVE INGREDIENT7SEV7J4R1UMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6

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 18 · 344 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
LEVONORGESTRELLEVONORGESTRELYYBA CORP5a71b870-9a0a-7997-e063-6294a90a882c2026-09-01WarningsExact identifier
unii: 5W7SIA7YZW
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals, Inc.90240210-0bca-4a55-99dc-19f2b40d8e3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SLYNDDROSPIRENONEExeltis USA, Inc.db32bc55-f295-4d87-9dbb-0a2f45573dcf2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 748797
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
IsibloomDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack4a8f278f-f505-4537-8deb-74e8927df8c62026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepacke0b07fb6-8dbd-4e5d-b589-5191a1dc02ae2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
SheWiseLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA7be13a7e-b4ff-4fe1-82a6-f9914596d72a2026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA07567b80-d8a1-41c0-95e4-33afa584bbc42026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
OPTION 2LEVONORGESTRELL. Perrigo Company7d7b9e61-9f3d-477d-b74d-b0cc725f9bba2026-06-25WarningsExact identifier
unii: 5W7SIA7YZW
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.78454ebf-f1a3-4ca0-b32e-88c51bc577732026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLA-S Medication Solutions6422dcc3-959a-4590-9ca8-9dcb58e682532026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.