FDA.reportPublic FDA data

NDC 68462-132-79 - Norethindrone Acetate 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
68462-132
Requested NDC
68462-132-79
Package NDCs from labels
68462-132-79, 68462-132-81
Manufacturer
A-S Medication Solutions
Effective date
2026-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Norethindrone Acetate and Ethinyl Estradiol - A-S Medication SolutionsA-S Medication Solutions2026-03-26HUMAN PRESCRIPTION DRUG LABEL
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP 1 mg/ 0.02 mg Rx onlyGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-01-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-132-79Norethindrone Acetate and Ethinyl Estradiol1 in 1 POUCHTABLET17
68462-132-79Norethindrone Acetate and Ethinyl Estradiol21 in 1 BLISTER PACKTABLET217
68462-132-81Norethindrone Acetate and Ethinyl Estradiol3 in 1 CARTONTABLET37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-132NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]6Current NDC, Legacy NDC, 3 package rows20240628_5a44f7a2-45f1-4d28-b9fb-61d9f2456422.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-132-79EA - Each68462-132ea025e82-e5a4-42b5-82f2-756e4ca8f52112016-06-14
68462-132-81EA - Each68462-13200a065c2-cf51-4171-a731-2a172773271712016-06-14

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 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5a44f7a2-45f1-4d28-b9fb-61d9f24564222026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206969
ndc (package): 68462-132-81
ndc (package): 68462-132-79
ndc (product): 68462-132
ndc11 (package): 68462013279
rxcui: 1358776
rxcui: 1358762
spl id: 0f4e690d-1b9a-4c51-ac0a-8aa783056a00
spl set id: 5a44f7a2-45f1-4d28-b9fb-61d9f2456422
unii: 423D2T571U
unii: 9S44LIC7OJ
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
Norethindrone AcetateNORETHINDRONE ACETATEGlenmark Pharmaceuticals Inc., USAd0a94321-eb60-4aa6-a429-f0156f9f8e012026-01-29Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
HAILEY Fe 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEGlenmark Pharmaceuticals Inc., USA72bd59e6-26cb-4c01-9511-586372b768b22026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Norethindrone AcetateNORETHINDRONE ACETATEAmerican Health Packagingeb0b80e0-5b69-4efa-ae8a-62e718a62dc32026-01-14Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Junel Fe 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATEPreferred Pharmaceuticals Inc.75bb0024-8f1a-4036-9acd-006ea430f3b72026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
Southeast Regional 1024SOUTHEAST REGIONALProfessional Complementary Health Formulas7a4ff3cf-6897-4cca-b907-556270642e042026-01-08WarningsExact identifier
unii: 5C5403N26O
Trees 2 1017TREES 2Professional Complementary Health Formulas601c8ffe-35c2-4dcc-a503-7d9b9998e2842026-01-08WarningsExact identifier
unii: 5C5403N26O
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Larin Fe 1/20NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATENorthstar Rx LLCe71741c8-10fa-4eee-b0da-e42af451222c2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
Larin 24 FeNORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATENorthstar Rx LLCea35800c-9a31-42b0-bb32-3404dce9e0e52025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762

Reported adverse events (FAERS/openFDA)#

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