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 49 of 104 · 2,065 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Path Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDELULUS SPA BOUTIQUE37657755-fa82-88a0-e063-6394a90ade472025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare376468ce-8d9b-b672-e063-6294a90a0bd12025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare37643884-f186-fb54-e063-6394a90a450f2025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8208b-7328-1891-e063-6294a90abdd92025-12-08Exact identifier
unii: 15FIX9V2JP
Protect Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8dedc-0575-9819-e063-6394a90afebf2025-12-08Exact identifier
unii: 15FIX9V2JP
Protect Mineral Stick ClearTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bfa392-dfec-bd8a-e063-6394a90acffa2025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b9d646-e049-6781-e063-6294a90ab1012025-12-08Exact identifier
unii: 15FIX9V2JP
Protect Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35c044a6-90be-55f8-e063-6294a90aad482025-12-08Exact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUMOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ed877-2926-1fd9-e063-6394a90aa1532025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMELOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f1ad4c-af9a-c998-e063-6294a90a15db2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TANOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f37a57-47ce-4175-e063-6394a90a92ee2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
RECHARGE Protect BlurTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCc787e3b9-33b1-4c47-95bd-b14cf65589382025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
unii: 15FIX9V2JP
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
unii: 15FIX9V2JP
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.a8955f3b-afc9-4ef0-8946-9c97ab5b2e052025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201663
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA, Inc.86eea4df-4191-4e05-9f05-4a98ef8c2a4d2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sun Tinted Face SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.22413f93-7219-4726-b741-2392e576b34a2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDEKingdom Animalia, LLC DBA Hourglass Cosmetics28e23498-953f-47c0-838c-bbf0e858d9032025-11-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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