NDC 0378-7192 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

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: 0378-7192
Package NDCs from labels: 0378-7192-59
Manufacturer: Mylan Pharmaceuticals Inc.
Effective date: 2021-11-29
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 - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2021-11-29	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-7192-59	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	9 in 1 BLISTER PACK	TABLET	9	35 ug	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-7192	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE KIT [MYLAN PHARMACEUTICALS INC.]	3	Unmatched	20250221_054917fa-573b-4b16-a719-ece6c0909656.zip

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 28 of 39 · 761 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lymphastat	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUM	Energique, Inc.	95406534-526e-4bca-b73d-1030623549a3	2024-03-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Snore-Soothe	ECHINACEA, BRYONIA, CAMPHORA, CISTUS CANADENSIS, DROSERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, IODIUM, KALI BICHROMICUM, KALI IODATUM, PHOSPHORUS, PULSATILLA, SABADILLA, SILICEA, STICTA PULMONARIA, SULPHUR, TEUCRIUM MARUM, VERBASCUM THAPSUS, ARSENICUM ALBUM, BELLADONNA, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, NUX VOMICA	Newton Laboratories, Inc.	140a0bcf-82b3-c430-e063-6294a90ad38f	2024-03-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Dizzy	CEREBELLUM (SUIS), BRYONIA (ALBA), PETROLEUM, TABACUM, AMBRA GRISEA, CYCLAMEN EUROPAEUM, NATRUM SALICYLICUM, ARGENTUM NITRICUM, ASARUM CANADENSE, CALCAREA SULPHURICA, CARBONEUM SULPHURATUM, CHININUM SULPHURICUM, COCCULUS INDICUS, CONIUM MACULATUM, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, PIPER METHYSTICUM, SILICEA, THERIDION	Deseret Biologicals, Inc.	fdf934f8-7b12-4076-b8fb-00c095940697	2024-03-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ver	ARTEMISIA VULGARIS, ASCARIS LUMBRICOIDES, BRUGIA MALAYI, CALCAREA CARBONICA, CINA, CRYPTOSPORIDIUM PARVUM, ENTEROBIUS VERMICULARIS, FILIX MAS, GIARDIA LAMBLIA, GRAPHITES, IODIUM, MERCURIUS CORROSIVUS, QUASSIA (AMARA), SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TAENIA SAGINATA, TAENIA SOLIUM, TEUCRIUM MARUM, THYMUS SERPYLLUM, TRICHINELLA SPIRALIS, TRICHOMONAS VAGINALIS	Deseret Biologicals, Inc.	b47bdd57-14cd-46e9-a34e-0d8a7c21bda2	2024-03-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Elevate	LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)	Deseret Biologicals, Inc.	5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b	2024-03-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Spinalmax	BERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM	Deseret Biologicals, Inc.	6c569331-2167-44bb-ace6-13340e7d8d6a	2024-03-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
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
Perfect Sleep	ADENOSINUM TRIPHOSPHORICUM DINATRUM, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH), L-TRYPTOPHAN, MELATONIN, MERCURIUS CORROSIVUS, PANTOTHENIC ACID, PASSIFLORA INCARNATA, PINEAL GLAND (SUIS), PYRROLE, SARCOLACTICUM ACIDUM, SILICEA, UBIDECARENONUM, ZINCUM VALERIANICUM	Deseret Biologicals, Inc.	81f29472-a2e6-486d-aefd-17135ad410ef	2024-03-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
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
LO LOESTRIN FE	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL AND FERROUS FUMARATE	A-S Medication Solutions	e2f24e91-4893-40bf-b310-d93db95d2442	2024-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 259176
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
Kidney Drainage	SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM	Deseret Biologicals, Inc.	a030afc6-9248-4e6a-a814-bd700c053e5c	2024-02-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Junel Fe 24	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Teva Pharmaceuticals USA, Inc.	ffbf48de-0f61-49f9-9cd5-6eb8e08040db	2024-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1358762 rxcui: 259176
Cough	IPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXIN	Deseret Biologicals, Inc.	4a8deb4a-9f26-46a9-8d99-99df36407f22	2024-02-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Perfect Sleep	ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)	Deseret Biologicals, Inc.	6d934960-63c6-4536-bde3-38c26f8083dc	2024-02-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
OSHIH	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Aurobindo Pharma Limited	7c07e339-3aae-4c77-a170-e6715bbe7563	2024-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 259176
Silicea	SILICON DIOXIDE	SEVENE USA	0805d866-ce1a-4f54-8a44-83d4902e8c0d	2024-01-30	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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