NDC 0093-5328-28 - Junel Fe 24

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
0093-5328
Requested NDC
0093-5328-28
Package NDCs from labels
0093-5328-28, 0093-5328-62
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2024-02-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Junel Fe 24 - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2024-02-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-5328-28Junel Fe241 in 1 POUCHKIT113
0093-5328-28Junel Fe241 in 1 BLISTER PACKKIT113
0093-5328-62Junel Fe243 in 1 CARTONKIT313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5328JUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA, INC.]13Current NDC, Legacy NDC, 3 package rows20240224_ffbf48de-0f61-49f9-9cd5-6eb8e08040db.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5328-28EA - Each0093-532839561508-22cd-4e89-ab4b-a069c61126c912015-06-09
0093-5328-62EA - Each0093-53281e688694-ce35-4d8b-adc2-06a9d8e5a23b12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
NORETHINDRONEACTIVE MOIETYT18F433X4SJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
ACACIAINACTIVE INGREDIENT5C5403N26OJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933JUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
FERROUS FUMARATEINACTIVE INGREDIENTR5L488RY0QJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30JUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJJUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554JUNEL FE 24 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA PHARMACEUTICALS USA 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 11 · 218 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
Mirexa MiniMIREXA MINIOncora Pharma, LLCea48f64a-9a70-40df-ba25-0983532730892026-08-25Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERREMEDYREPACK INC.5d67a268-437b-403d-9d05-6524c4a7c4992026-08-11WarningsExact identifier
unii: R5L488RY0Q
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENTAcella Pharmaceuticals, LLC038fe2e7-dc16-485c-b5fb-746db72313472026-07-23Boxed warning, Adverse reactionsExact identifier
unii: R5L488RY0Q
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
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
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
Minovia MiniMINOVIA MINIOncora Pharma, LLC297673c1-23db-47b5-8cfb-aaecc07908382026-06-24Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
BoosterviteMULTIVITAMINPureTek Corporation53efbf65-8844-8486-e063-6394a90a51d32026-06-18Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: R5L488RY0Q
VitaluxMULTIVITAMINPureTek Corporation52d5eee7-8146-cc62-e063-6394a90a8c3f2026-06-02Boxed warning, Adverse reactionsExact identifier
unii: R5L488RY0Q
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEIngenus Pharmaceuticals, LLC50c786d6-91bd-4eea-9455-ff2abc08372f2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Junel Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEPD-Rx Pharmaceuticals, Inc.93a2f8c9-3550-42ec-8f76-3ac9badf4bb22026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
rxcui: 259176

Reported adverse events (FAERS/openFDA)#

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