NDC 0378-7274-85 - 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: 0378-7274
Requested NDC: 0378-7274-85
Package NDCs from labels: 0378-7274-85, 0378-7274-53
Manufacturer: Mylan Pharmaceuticals Inc.
Effective date: 2024-01-15
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1.5 mg/0.03 mg	Mylan Pharmaceuticals Inc.	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0378-7274-53	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	3 in 1 CARTON	TABLET	3	6
0378-7274-85	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	1 in 1 POUCH	TABLET	1	6
0378-7274-85	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	21 in 1 BLISTER PACK	TABLET	21	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-7274	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]	5	Current NDC, Legacy NDC, 3 package rows	20250221_3108a9bc-3378-459d-8f6b-bd5eff2ad657.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-7274-53	EA - Each	0378-7274	69756ed9-63ef-4c23-95dd-81b86ce817fa	1	2019-10-07
0378-7274-85	EA - Each	0378-7274	c7bd30bf-48a1-49ec-82af-d4d2f5917156	1	2019-10-07

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 5 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glyreg	ACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCA	Deseret Biologicals, Inc	28e670ca-ed35-4256-af20-74c25dc18099	2024-04-23	Warnings	Exact identifier unii: C151H8M554
Microgestin Fe 1.5/30	NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE	Dr. Reddys Laboratories Inc	17b4ee33-3ec1-440d-9446-f20c51629c2d	2024-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1359022
Microgestin Fe 1.5/30	NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE	Proficient Rx LP	03053e47-c9ac-42bd-b4cd-3e911564676a	2024-04-01	Warnings, Adverse reactions	Exact identifier rxcui: 1359022
Envirotox	TRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.	BioActive Nutritional, Inc.	2b5cfdba-cf4d-4eb0-8c60-20eac6922663	2024-03-26	Warnings	Exact identifier unii: 368GB5141J
Habit	CHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUS	Deseret Biologicals, Inc.	3d00a305-e15d-4419-97bd-332421d4a1b0	2024-03-15	Warnings	Exact identifier unii: C151H8M554
Leaky Gut Formula	ALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)	Deseret Biologicals, Inc.	7e3a254b-a43d-43a2-a777-0d0c0057e131	2024-03-14	Warnings	Exact identifier unii: C151H8M554
NUVARING	ETONOGESTREL AND ETHINYL ESTRADIOL	A-S Medication Solutions	e14bc197-dd22-4e6e-8aa1-d6cf2242fe0f	2024-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 423D2T571U
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	9d4c4d88-43da-49dd-e053-2995a90af18d	2024-03-07	Warnings	Exact identifier unii: C151H8M554
Cand Plus	HYDRASTIS CANADENSIS, BERBERIS VULGARIS, BORAX, SACCHARUM OFFICINALE, CAFFEINUM, GALLICUM ACIDUM, INDOLUM, ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), ASAFOETIDA, ACETALDEHYDE, FOLLICULINUM, LYCOPODIUM CLAVATUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), SEPIA, USTILAGO MAIDIS, TORULA CEREVISIAE	Deseret Biologicals, Inc.	1f8ab864-27c2-4457-8ad7-5d65f9983e2c	2024-03-06	Warnings	Exact identifier unii: C151H8M554
Etyqa	ESTRADIOL AND NORETHINDRONE ACETATE	Aurobindo Pharma Limited	afbc2a33-5eb2-4f01-91e9-07d8050da6ce	2024-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9S44LIC7OJ
Jinteli	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	d667ca75-1a17-43fc-9077-f25ce0908f8d	2024-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 423D2T571U unii: 9S44LIC7OJ
XULANE	NORELGESTROMIN AND ETHINYL ESTRADIOL	A-S Medication Solutions	adcf17ef-e60b-48a4-9478-3998dab2bbbd	2024-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 423D2T571U
CombiPatch (estradiol/norethindrone acetate transdermal system)	ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM	Noven Therapeutics, LLC	83198ef1-11c4-11e4-9191-0800200c9a66	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9S44LIC7OJ
Estradiol / Norethindrone Acetate	ESTRADIOL AND NORETHINDRONE ACETATE	Breckenridge Pharmaceutical, Inc.	44125b2f-10ac-435c-bdb4-a29bf8450dbf	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9S44LIC7OJ
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	3108a9bc-3378-459d-8f6b-bd5eff2ad657	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA202770 ndc (package): 0378-7274-85 ndc (package): 0378-7274-53 ndc (product): 0378-7274 ndc11 (package): 00378727485 rxcui: 1359022 rxcui: 1359028 spl id: 8a7faa9f-224f-fb2e-fde2-986d2142dc2f spl set id: 3108a9bc-3378-459d-8f6b-bd5eff2ad657 unii: 423D2T571U unii: 9S44LIC7OJ
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	89948751-bd6e-4e9c-b87c-8782706c1097	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 423D2T571U unii: 9S44LIC7OJ
Quflora Pediatric	VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDE	CarWin Pharmaceutical Associates, LLC	b8e08798-d8bb-4616-996b-a2c07a5d730a	2024-01-10	Warnings, Adverse reactions	Exact identifier unii: 7QWA1RIO01
A04 DEEP ANTITOX	ALLIUM CEPA, ALLIUM SATIVUM, ALOE SOCOTRINA, ARSENICUM IODATUM, ASTERIAS RUBENS, BAPTISIA TINCTORIA, CALCAREA IODATA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINA, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, INDOLUM, LAC VACCINUM, LACTICUM ACIDUM, MILLEFOLIUM, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SCROPHULARIA NODOSA, SKATOLUM, SOLIDAGO VIRGAUREA, SULPHUR, URICUM ACIDUM	Apex Energetics Inc.	b9bbbddf-b822-4780-e053-2a95a90afbba	2024-01-08	Warnings	Exact identifier unii: C151H8M554
B05 GLUCO BALANCE	ADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUM	Apex Energetics Inc.	bae9ff7e-eb69-c61d-e053-2995a90a2627	2024-01-08	Warnings	Exact identifier unii: C151H8M554
ZAFEMY	NORELGESTROMIN AND ETHINYL ESTRADIOL	Bryant Ranch Prepack	77230a20-4269-4abf-ae2a-ac5ccafef565	2024-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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