NDC 0378-1817-01 - Levothyroxine Sodium

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: 0378-1817
Requested NDC: 0378-1817-01
Package NDCs from labels: 0378-1817-77, 0378-1817-10, 0378-1817-01
Manufacturer: Mylan Institutional Inc.
Effective date: 2025-07-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Levothyroxine Sodium - Mylan Institutional Inc.	Mylan Institutional Inc.	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2024-04-15	HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - A-S Medication Solutions	A-S Medication Solutions	2023-08-14	HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - A-S Medication Solutions	A-S Medication Solutions	2023-08-09	HUMAN PRESCRIPTION DRUG LABEL
LEVOTHYROXINE SODIUM - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-03-23	HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2010-08-19	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-1817-10	Levothyroxine Sodium	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		31
0378-1817-77	Levothyroxine Sodium	90 in 1 BOTTLE, GLASS	TABLET	90		31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1817	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	31	Legacy NDC, 2 package rows	20240801_e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1817-01	EA - Each	0378-1817	e26ffa17-d3c1-4fcf-b965-fbd64f17bc05	1	2012-07-24
0378-1817-04	EA - Each	0378-1817	312b058b-ff3e-4eb9-a740-7a5ec8f8307c	1	2020-09-14
0378-1817-05	EA - Each	0378-1817	7ffceb3b-6f2d-43b6-9d51-b67851c3dbf2	1	2013-02-13
0378-1817-10	EA - Each	0378-1817	edd82c39-ae26-42f9-8bb3-279b02b2d55b	1	2012-07-24
0378-1817-77	EA - Each	0378-1817	0f3f24fb-19e9-44be-9e9e-577a8b56064b	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2

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 49 of 49 · 977 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrate II	BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA	Zorex International	e5f53495-3b75-4d7c-89af-23058fb6fd05	2018-12-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Dust Mix Antigen	ANTIMON TART, ARSENICUM ALB, BLATTA OR, BROMIUM, CALC CARB, CIMEX, DROSERA, HEPAR SULPH CALC, ICTODES FOETIDA, LYCOPODIUM, PHOS, PULSATILLA, SILICEA TERRA, TABACUM FUMUS	Natural Creations, Inc	8dab4b4a-6fa8-4258-adc1-f8c634e2030b	2018-12-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
HA HP	BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIA	BioActive Nutritional, Inc.	30f6c191-ce6e-438c-9601-74f5e8b61f96	2018-07-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Immuno Fortifier	ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEA	BioActive Nutritional, Inc.	04024663-0b11-438a-a21a-8e86edd8052a	2018-01-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
H-Acne Formula	CALENDULA OFFICINALIS, NUX VOMICA, SILICEA	Healing Natural Oils LLC	fd9598ac-8f69-4fba-99c1-4234c8afcafd	2017-12-27	Warnings	Exact identifier unii: ETJ7Z6XBU4
H-Nail Fungus Formula	CALENDULA OFFICINALIS, SILICEA, THUJA OCCIDENTALIS	Healing Natural Oils LLC	68f87ae5-fa3a-45cf-971c-c09e98106dd8	2017-12-27	Warnings	Exact identifier unii: ETJ7Z6XBU4
Homeoplex F	ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEA	Supplement Clinic, LLC.	a1872d34-7298-4016-b7b3-830ac1149126	2017-11-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
Homeoplex P	ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), SCROPHULARIA NODOSA, TABEBUIA IMPETIGINOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUM	Supplement Clinic, LLC.	3c0450c8-956e-4788-9e4d-55d30052ca0b	2017-11-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
Pertussis	ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, IPECACUANHA, STICTA PULMONARIA, TABACUM, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, SILICEA, PERTUSSINUM, TETANUS TOXIN	Deseret Biologicals, Inc.	b50b5a93-dbb5-4be9-91ac-7513f0ee3410	2017-10-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Teething-HP	BORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLINUM, SILICEA	BioActive Nutritional, Inc.	1758624d-7ed8-49a6-ab24-2aab57703c91	2017-06-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
Parathyroplex	PARATHYROID GLAND (BOVINE), BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, RHUS TOX, SILICEA	BioActive Nutritional, Inc.	37649bb9-cbd7-4971-b410-18ea307c46f6	2017-04-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)	Energetix Corp	9883c502-9782-451e-9eec-c54d7b054f31	2017-01-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tox-Chord	ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM	Energetix Corp	6b0d1628-b20d-426e-9c84-5cceadca3f45	2016-11-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Thyrotox	CHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEA	BioActive Nutritional, Inc.	e229a260-13f3-4136-b325-9a8954f8a327	2016-08-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Teething	ARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEA	BioActive Nutritional, Inc.	f39c9feb-f567-43a2-a026-2a581aeeed9d	2016-07-27	Warnings	Exact identifier unii: ETJ7Z6XBU4
54642793-18db-4fca-9056-a2ca5a740e59			71139e30-10c8-4474-b7a3-b575c3fd32f9	2011-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 54642793-18db-4fca-9056-a2ca5a740e59 spl set id: 71139e30-10c8-4474-b7a3-b575c3fd32f9
feb3b39a-cb33-4b75-8ed9-a991ee25d31e			b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2010-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: feb3b39a-cb33-4b75-8ed9-a991ee25d31e spl set id: b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4

Reported adverse events (FAERS/openFDA)#

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