FDA.reportPublic FDA data

NDC 0378-7287-85 - LEVONORGESTREL 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
0378-7287
Requested NDC
0378-7287-85
Package NDCs from labels
0378-7287-85, 0378-7287-53
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2022-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mgMylan Pharmaceuticals Inc.2022-08-31HUMAN PRESCRIPTION DRUG LABEL
LEVONORGESTREL AND ETHINYL ESTRADIOL - A-S Medication SolutionsA-S Medication Solutions2018-02-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-7287-53LEVONORGESTREL AND ETHINYL ESTRADIOL3 in 1 CARTONKIT314
0378-7287-85LEVONORGESTREL AND ETHINYL ESTRADIOL1 in 1 BLISTER PACKKIT114
0378-7287-85LEVONORGESTREL AND ETHINYL ESTRADIOL1 in 1 POUCHKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7287LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 3 package rows20250221_c3c00dc0-8834-45fb-9f5b-810a98cef59d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7287-53EA - Each0378-7287d20cdebc-3c75-44a1-b637-da1495eadf2d12014-07-02
0378-7287-85EA - Each0378-7287b017bafe-6b4b-4452-8d95-34e60e296aa212018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35LEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2

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 18 · 355 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
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
LEVONORGESTRELLEVONORGESTRELYYBA CORP5a71b870-9a0a-7997-e063-6294a90a882c2026-09-01WarningsExact identifier
unii: 5W7SIA7YZW
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
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SLYNDDROSPIRENONEExeltis USA, Inc.db32bc55-f295-4d87-9dbb-0a2f45573dcf2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 748797
TyblumeLEVONORGESTREL AND ETHINYL ESTRADIOLExeltis USA, Inc.b2482d51-d606-4aaa-8af4-19e4fe2f88722026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242297
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
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
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SheWiseLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA7be13a7e-b4ff-4fe1-82a6-f9914596d72a2026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA07567b80-d8a1-41c0-95e4-33afa584bbc42026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
Gwyn LoNORELGESTROMIN AND ETHINYL ESTRADIOLViatris Specialty LLCe92741f4-87fe-429f-b5b5-c558ed5f4fa92026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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