FDA.reportPublic FDA data

NDC 68180-837-11 - norgestimate 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
68180-837
Requested NDC
68180-837-11
Package NDCs from labels
68180-837-73, 68180-837-11, 68180-837-13
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-07-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
norgestimate and ethinyl estradiol - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2026-07-29HUMAN PRESCRIPTION DRUG LABEL
TRI-LO-MARZIA - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-12-09HUMAN PRESCRIPTION DRUG LABEL
TRI-LO-MARZIA - A-S Medication SolutionsA-S Medication Solutions2024-03-10HUMAN PRESCRIPTION DRUG LABEL
TRI-LO-MARZIA - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2019-12-30HUMAN PRESCRIPTION DRUG LABEL
TRI-LO-MARZIA - Proficient Rx LPProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-837-73TRI-LO-MARZIA3 in 1 CARTONKIT314
68180-837-73TRI-LO-MARZIA1 in 1 POUCHKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-837TRI-LO-MARZIA ( NORGESTIMATE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 2 package rows20250223_bc402baa-5de4-4149-9857-081a9b4eb280.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-837-11EA - Each68180-8374fd112eb-ce71-4edc-b946-68204dc9177512016-02-04
68180-837-13EA - Each68180-8378ff8de42-cadb-4640-be96-28d3c455568512016-02-04
68180-837-71EA - Each68180-8376229465b-c9f6-4dd6-96f6-bbc2aed3230712020-02-13
68180-837-73EA - Each68180-837c56eee6e-d255-4bee-9f90-378da3439fb712020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
NORGESTIMATEACTIVE MOIETYC291HFX4DYTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]4

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 125 · 2,486 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
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
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals, Inc.90240210-0bca-4a55-99dc-19f2b40d8e3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.58e85e02-93e7-42ba-b8f5-a36290c684232026-08-31Boxed 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 Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
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
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
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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