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 67 of 104 · 2,061 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDf106f52b-2157-46c7-9f7c-50f43a6490502025-01-09WarningsExact identifier
unii: 15FIX9V2JP
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEETHEREAL AESTHETICS LLC065d17cf-bea5-137f-e063-6394a90aeeb32025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESERRAO, E JOHN MD FACOGfea61544-6684-ad34-e053-6294a90a48f32025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENew Beginnings Tattoo Removalfea87de3-116f-4774-e053-6394a90a0aad2025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPURA VIDA BODY & MIND SPA, INC.04b38e97-c4b3-df23-e063-6394a90ae6b72025-01-08WarningsExact identifier
unii: 15FIX9V2JP
EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPremier Plastic Surgerybc9221fe-89b4-4ad8-e053-2995a90aa0412025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEEmerald Aesthetics LLCf80f439d-f4f0-fbf3-e053-6294a90ae0ef2025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESuzanne's Skin2soul LLCfea667a1-6bec-9819-e053-6394a90a9b962025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBEAUTY SENSE MEDSPA INCfe93a337-8d2f-35d3-e053-6294a90acb3c2025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 56 Sunscreen Stick SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC92c4e4cb-aadc-26f4-e053-2995a90a03d52025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 56 Sunscreen Compact SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb8a4986d-c28f-c4f4-e053-2a95a90a71672025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC8f119447-045b-43f3-e053-2995a90aea772025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 75 Sunscreen Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb878ee3b-6897-3c4a-e053-2995a90afed72025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 70 Sunscreen SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb879067b-9d7f-3a62-e053-2995a90a9d6b2025-01-06WarningsExact identifier
unii: 15FIX9V2JP
glo SKIN BEAUTY Luminous Liquid Foundation SPF 18GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18Hayden Caleel LLCdd863361-281d-45fe-a8c1-6e4c670809a52025-01-05WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jucre Rebirth BBTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, NIACINAMIDE, ADENOSINENATURECELL CO., LTD.2ab403df-29b3-75af-e063-6394a90a6ca42025-01-02WarningsExact identifier
unii: 15FIX9V2JP
Green Defense Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEFarmacy Beauty LLCadf0f50f-6357-bc1f-e053-2a95a90ad9972025-01-02WarningsExact identifier
unii: 15FIX9V2JP
Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plusOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.283c2780-5ad5-38f1-e063-6294a90ac3362025-01-01WarningsExact identifier
unii: 15FIX9V2JP
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aabf782-65f9-e894-e063-6394a90a1ea32025-01-01WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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