FDA.reportPublic FDA data

NDC 0378-7300-85 - 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
0378-7300
Requested NDC
0378-7300-85
Package NDCs from labels
0378-7300-85, 0378-7300-53
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2023-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DROSPIRENONE AND ETHINYL ESTRADIOL - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2023-09-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-7300-53DROSPIRENONE AND ETHINYL ESTRADIOL3 in 1 CARTONKIT312
0378-7300-85DROSPIRENONE AND ETHINYL ESTRADIOL1 in 1 BLISTER PACKKIT112
0378-7300-85DROSPIRENONE AND ETHINYL ESTRADIOL1 in 1 POUCHKIT112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7300DROSPIRENONE AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 3 package rows20250221_25f9b952-cc1d-454e-a3ec-834ba1774b6b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7300-53EA - Each0378-730020d3bae2-17f5-4c33-bcba-599bdb0aaf0512015-09-10
0378-7300-85EA - Each0378-73003013c403-bf5a-4402-b289-ae5ead4bef5512022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DROSPIRENONEACTIVE INGREDIENTN295J34A25DROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UDROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
DROSPIRENONEACTIVE MOIETYN295J34A25DROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UDROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUDROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35DROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]3

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 4 of 12 · 221 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SETLAKINLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCb7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.35eb35e6-d9a0-4472-94ac-aa470ccba5672025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.a8955f3b-afc9-4ef0-8946-9c97ab5b2e052025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748800
rxcui: 748797
rxcui: 284207
VyfemlaNORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.175ce5c4-d332-4c97-a0b8-10821dc813ef2025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JuleberDESOGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCde9a2d1b-15f6-453f-b36b-1c2a43c4918d2025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLOrganon LLC55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d972025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Zovia 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETSMayne Pharma Inc.d0d2a9e9-e9ce-4a42-b429-5c1f9a5447952025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 748797
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals Inc.1f8b9aad-f31f-4cda-861d-c08a977fc9232025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NeconNORETHINDRONE AND ETHINYL ESTRADIOLMayne Pharma Inc.e80714f4-cdfe-4d60-a4e1-b8c7b184cc462025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLMayne Pharma Inc.bff09a7b-aea6-460b-a263-44576e00f5102025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 748797
Aubra EQLEVONORGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack5bebc7e2-d085-410c-bae1-7d758d3c20162025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Drospirenone and Ethinyl EstradiolDROSPIRENONE AND ETHINYL ESTRADIOLNorthStar Rx LLCc88c3eb8-3bf5-4004-a7ab-7218cd2f91822025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AyunaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited2b54ce42-db64-46c3-a788-569e21f7ab062025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Aubra EQLEVONORGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC61207a91-8b3c-4231-b98f-3cb9f4a4be092025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AfirmelleLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limiteddd6122cd-b7ba-4fe3-bde5-910882475b672025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Chateal EQLEVONORGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC4c59652c-49a6-4eed-b557-9abd3ffac5412025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Low-OgestrelNORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.8755b020-d439-4ba2-a60b-6c57a15ece552025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LuteraLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.b91ad328-f2f4-4f7d-82d3-daaada95f5092025-07-28Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevoraLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.31679b9f-58c9-4bf1-8c2c-f5a216ff4cd32025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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