FDA.reportPublic FDA data

NDC 68462-672-91 - levonorgestrel and ethinyl estradiol

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
68462-672
Requested NDC
68462-672-91
Package NDCs from labels
68462-672-91, 68462-672-95
Manufacturer
Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited
Effective date
2026-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
levonorgestrel and ethinyl estradiol - Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-01-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-672-91levonorgestrel and ethinyl estradiol1 in 1 BLISTER PACKKIT16
68462-672-91levonorgestrel and ethinyl estradiol1 in 1 POUCHKIT16
68462-672-95levonorgestrel and ethinyl estradiol3 in 1 CARTONKIT36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-672LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]5Current NDC, Legacy NDC, 3 package rows20230301_3d87d9a4-860a-4ea7-a993-0f4adf1789da.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-672-91EA - Each68462-67214593737-db16-4c3b-b589-3f6301de7c0212015-07-20
68462-672-95EA - Each68462-672d328204a-f67c-4880-8f5a-b1eda39fc73812015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1

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 117 · 2,325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
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
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
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

Reported adverse events (FAERS/openFDA)#

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