FDA.reportPublic FDA data

NDC 0555-9064-79 - Kelnor 1/35

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
0555-9064
Requested NDC
0555-9064-79
Package NDCs from labels
0555-9064-79, 0555-9064-58
Manufacturer
A-S Medication Solutions
Effective date
2023-02-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Kelnor 1/35 - A-S Medication SolutionsA-S Medication Solutions2023-02-04HUMAN PRESCRIPTION DRUG LABEL
Kelnor 1/35 - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2022-10-19HUMAN PRESCRIPTION DRUG LABEL
Kelnor 1/35 - Physicians Total Care, Inc.Physicians Total Care, Inc.2011-01-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9064-58Kelnor 1/356 in 1 CARTONKIT614
0555-9064-79Kelnor 1/351 in 1 BLISTER PACKKIT114
0555-9064-79Kelnor 1/351 in 1 POUCHKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9064KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 3 package rows20221022_96a73786-22b1-457e-be73-80b699996d40.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9064-58EA - Each0555-9064d4998f1c-bc55-4ac0-a3f2-db451e00912c12013-02-13
0555-9064-67EA - Each0555-90643b1d2b3a-6905-4a04-a521-78c38a7ce2c812013-02-13
0555-9064-79EA - Each0555-90642c483d70-de9a-4c65-851e-91f270d04dc612017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ETHYNODIOL DIACETATEACTIVE INGREDIENT62H10A1236KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ETHYNODIOLACTIVE MOIETY9E01C36A9SKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHYNODIOL DIACETATEACTIVE INGREDIENT62H10A1236KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHYNODIOLACTIVE MOIETY9E01C36A9SKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POVIDONE K12INACTIVE INGREDIENT333AG72FWJKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, 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 2 of 17 · 327 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
GUNA-BOWELALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA COLON - SUS SCROFA RECTUM - TARAXACUM OFFICINALE - THIAMINE -Guna spa75465821-a889-4697-b470-e9588a5232052026-06-10WarningsExact identifier
unii: LMI26O6933
Borago NicotianaBORAGO NICOTIANAUriel Pharmacy Inc.306f9eee-877b-46ee-9a36-894fa321b3d32026-06-05WarningsExact identifier
unii: LMI26O6933
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
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: 748797
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
WeraNORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLC638e4f36-1a27-4220-8ec9-3fa9d9b36c112026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Dasetta 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLCda52e74a-1baf-4a33-a068-b491767003202026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLA-S Medication Solutions38924c83-53aa-4279-8f0e-1a5d8f5fd8ad2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
VesturaDROSPIRENONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.c6f63cc0-11b0-4320-a9ef-5bd5c9b16fd52026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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