FDA.reportPublic FDA data

NDC 68180-902-71 - 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
68180-902
Requested NDC
68180-902-71
Package NDCs from labels
68180-902-71, 68180-902-73, 68180-902-11, 68180-902-13
Manufacturer
Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date
2022-12-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
drospirenone and ethinyl estradiol - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2022-12-28HUMAN PRESCRIPTION DRUG LABEL
DROSPIRENONE AND ETHINYL ESTRADIOL - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2021-01-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-902-11EA - Each68180-90201349e23-0e95-4eda-bf2b-88e2f4208c5612013-02-13
68180-902-13EA - Each68180-9024eb06ebc-4c31-4640-b1ba-55ee397926c212013-02-13
68180-902-71EA - Each68180-90271ede554-2252-4f93-a2ff-2909607c389812021-05-05
68180-902-73EA - Each68180-9023ca32e5d-3787-4509-afed-f1fde40bc26012021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DROSPIRENONEACTIVE INGREDIENTN295J34A25DROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
DROSPIRENONEACTIVE MOIETYN295J34A25DROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]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 84 of 104 · 2,061 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AuraTITANIUM DIOXIDEChantecaille Beaute Incde441a6c-55e3-4b11-afb3-d7db3c6971f02024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 BlissTITANIUM DIOXIDEChantecaille Beaute Inc16d9e226-7694-922a-e063-6394a90aea852024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 GlowTITANIUM DIOXIDEChantecaille Beaute Incf868fe4f-4c10-4f0f-9f1d-008f067744082024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 NudeTITANIUM DIOXIDEChantecaille Beaute Inccb8feddc-ae98-42ea-ad1e-583dcacfa5d92024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 OpalineTITANIUM DIOXIDEChantecaille Beaute Inc1c918b4b-763b-48bf-9ae3-661eabafee162024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TanTITANIUM DIOXIDEChantecaille Beaute Incfdf05545-5a21-4238-b0d3-e3fcdfe866ff2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TopazTITANIUM DIOXIDEChantecaille Beaute Inc2012f671-7889-4e29-b70f-215cbc9dbdc72024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 VanillaTITANIUM DIOXIDEChantecaille Beaute Inc7133c47d-ed1c-43e9-8cdf-42f7b2f215f52024-04-24WarningsExact identifier
unii: 15FIX9V2JP
SPF30 Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC37d696d9-f89d-498e-8fe9-1f08d05d7b612024-04-18WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Daily Facial Moisturizer with suncreen SPF 50OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDEGalderma Laboratories, L.P.6650d137-e69e-4ec2-8311-3de74bf213152024-04-17WarningsExact identifier
unii: 15FIX9V2JP
SPF 30 Mineral Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC0bc21573-d302-4d85-8d8f-dca9a48e1f352024-04-17WarningsExact identifier
unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
unii: 15FIX9V2JP
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact identifier
unii: 15FIX9V2JP
Daily Prevention Advanced Smartblend Mineral Moisturizer SPF 75TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs141bb721-cd1c-5bba-e063-6394a90ab8fa2024-03-20WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen-LotionZINC OXIDE, TITANIUM DIOXIDEShanghai Chuangshi Medical Technology (Group) Co., Ltd.0511ff57-b7bd-4708-e063-6294a90a58a82024-03-20WarningsExact identifier
unii: 15FIX9V2JP
Daily Prevention Pure Mineral Tinted Moisturizer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs13bc141b-a30f-2661-e063-6294a90aca2b2024-03-15WarningsExact identifier
unii: 15FIX9V2JP
BB Ambre 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13a3ec97-0d0a-d639-e063-6294a90a0bf82024-03-14WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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