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 1 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals, Inc.90240210-0bca-4a55-99dc-19f2b40d8e3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
IsibloomDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack4a8f278f-f505-4537-8deb-74e8927df8c62026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepacke0b07fb6-8dbd-4e5d-b589-5191a1dc02ae2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748800
rxcui: 748797
rxcui: 284207
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Gwyn LoNORELGESTROMIN AND ETHINYL ESTRADIOLViatris Specialty LLCe92741f4-87fe-429f-b5b5-c558ed5f4fa92026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.78454ebf-f1a3-4ca0-b32e-88c51bc577732026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLA-S Medication Solutions6422dcc3-959a-4590-9ca8-9dcb58e682532026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
TurqozNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse7a05138-91a5-4c66-a915-614576e0805a2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
KurveloLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.752f525e-1838-4058-9ab7-2c2d91f86dfd2026-05-20Boxed warning, WarningsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLApotex Corp.9187a357-e95d-4733-9627-f19522b863732026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748800
rxcui: 748797
rxcui: 284207
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Pharmaceuticals USA Inc.10fa1458-c8ed-4197-922a-1ba7271d2b022026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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