FDA.reportPublic FDA data

NDC 0093-3122-28 - Jinteli

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
0093-3122
Requested NDC
0093-3122-28
Package NDCs from labels
0093-3122-98, 0093-3122-28, 0093-3122-42
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2024-02-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Jinteli - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2024-02-27HUMAN PRESCRIPTION DRUG LABEL
Jinteli TM (northindrone acetate and ethinyl estradiol tablets, USP)Physicians Total Care, Inc.2011-02-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-3122-28Jinteli28 in 1 BLISTER PACKTABLET2812
0093-3122-42Jinteli5 in 1 CARTONTABLET512
0093-3122-98Jinteli90 in 1 BOTTLETABLET9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3122JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA, INC.]12Current NDC, Legacy NDC, 3 package rows20240307_d667ca75-1a17-43fc-9077-f25ce0908f8d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3122-28EA - Each0093-312244f56f5b-ab43-417e-bd12-670f69e5bb9b12015-11-12
0093-3122-42EA - Each0093-312241f77fb0-cd91-4a17-a14a-f7c364f8203312012-07-24
0093-3122-98EA - Each0093-312229597609-2afd-4e34-b434-aac5b0affd6112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC]5
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC]5
NORETHINDRONEACTIVE MOIETYT18F433X4SJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC]5
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC]5
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
NORETHINDRONEACTIVE MOIETYT18F433X4SJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJJINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1

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 4 · 69 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
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
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutionse166bdf6-eb60-49b8-9747-2a33c3e3461b2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutions1521007a-546d-421e-99e1-e10d90c0b0902026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEIngenus Pharmaceuticals, LLC50c786d6-91bd-4eea-9455-ff2abc08372f2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
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
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
unii: 9S44LIC7OJ
Junel FEJUNEL FEDirect_Rxea62a66e-d45d-11be-e053-2a95a90a78012026-03-17Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
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
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
rxcui: 1090992
unii: 423D2T571U
unii: 9S44LIC7OJ
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

Reported adverse events (FAERS/openFDA)#

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