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 4 of 117 · 2,325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
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
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLA-S Medication Solutions6422dcc3-959a-4590-9ca8-9dcb58e682532026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AshlynaLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLA-S Medication Solutions2004a53d-3f62-4c33-813a-94b1567fe4652026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238019
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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