FDA.reportPublic FDA data

NDC 68462-720-84 - drospirenone 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
68462-720
Requested NDC
68462-720-84
Package NDCs from labels
68462-720-84, 68462-720-29
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
drospirenone and ethinyl estradiol - Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-01-29HUMAN PRESCRIPTION DRUG LABEL
drospirenone and ethinyl estradiol - A-S Medication SolutionsA-S Medication Solutions2024-05-07HUMAN PRESCRIPTION DRUG LABEL
drospirenone and ethinyl estradiol - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
drospirenone and ethinyl estradiol - Proficient Rx LPProficient Rx LP2022-07-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-720-29drospirenone and ethinyl estradiol3 in 1 CARTONKIT39
68462-720-84drospirenone and ethinyl estradiol1 in 1 BLISTER PACKKIT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-720DROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8Current NDC, Legacy NDC, 2 package rows20230702_0f8f8a21-cee8-462f-98b3-6c06f2f33e0d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-720-29EA - Each68462-720dbd9d485-9cef-4048-9f32-bf4a90aec60d12015-10-02
68462-720-84EA - Each68462-720dda11773-efeb-48e8-b0e2-62b020fffea812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DROSPIRENONEACTIVE INGREDIENTN295J34A25DROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
DROSPIRENONEACTIVE MOIETYN295J34A25DROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35DROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDROSPIRENONE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDROSPIRENONE 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 2 of 122 · 2,429 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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: B697894SGQ
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
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: B697894SGQ
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: B697894SGQ
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
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
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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