FDA.reportPublic FDA data

NDC 68180-854-11 - 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
68180-854
Requested NDC
68180-854-11
Package NDCs from labels
68180-854-73, 68180-854-11, 68180-854-13
Manufacturer
Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date
2025-12-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ETHINYL ESTRADIOL - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-12-09HUMAN PRESCRIPTION DRUG LABEL
ETHINYL ESTRADIOL - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2019-06-27HUMAN PRESCRIPTION DRUG LABEL
Levonorgestrel and Ethinyl Estradiol - Central Texas Community Health CentersCentral Texas Community Health Centers2016-01-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-854-73Levonorgestrel and Ethinyl Estradiol3 in 1 CARTONKIT39
68180-854-73Levonorgestrel and Ethinyl Estradiol1 in 1 BLISTER PACKKIT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-854LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20250227_6e686b50-8d36-4a13-91a8-d4ad21cdb735.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-854-11EA - Each68180-85442ee7fbb-69ea-4f95-b405-3729c173bbf512013-07-02
68180-854-13EA - Each68180-8545117fd3a-3e84-4e85-89d8-e0fd6dbedc1712013-07-02
68180-854-71EA - Each68180-8545660cc29-38f6-461e-8df1-817283e4ae8512019-11-12
68180-854-73EA - Each68180-854dd9b5b63-78db-442e-b5c2-8b63a59fd0df12019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL 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 1 of 18 · 346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
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
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
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
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: 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
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
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
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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