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 43 of 49 · 977 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Grain and Seed Antigens	AMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR	BioActive Nutritional, Inc.	36ce44a5-e5ac-4eea-b76d-424dcd4e6b07	2023-06-20	Warnings	Exact identifier unii: C151H8M554
Calciforce	ARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICA	BioActive Nutritional, Inc.	1609ce3e-82c2-4597-86e6-847c944ddbe6	2023-06-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea 6X	SILICEA 6X	True Botanica, LLC	fd296871-c491-7d30-e053-6294a90ab64d	2023-06-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
Baby Nighttime Mucus Plus Cold Relief	CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA	Hyland's Inc.	736b2487-e81d-d172-e053-2a91aa0ab0cf	2023-04-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Radialgin	CITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAY	Nutritional Specialties, Inc.	f1414ae2-4068-4076-bf11-b57a34ba5df2	2023-04-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea	SILICON DIOXIDE	Boiron	86d34721-7dfc-bf91-e053-2991aa0a70ae	2023-03-27		Exact identifier unii: ETJ7Z6XBU4
Mannitol	MANNITOL	Fresenius Kabi USA, LLC	c395e13d-6ea1-4104-8b37-669cfb982f04	2023-03-16	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
NS Support	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,	Dr. Donna Restivo DC	807fd9cf-13d1-4173-a6da-180f89b67cf2	2023-03-15	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	Deseret Biologicals, Inc.	d29af0e7-0d04-47e3-9a50-d99c7e14b44d	2023-02-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Saccharum officinale	SUCROSE	Boiron	6858f374-8549-4b00-e053-2991aa0a5c3c	2023-02-20		Exact identifier unii: C151H8M554
Silicea	SILICON DIOXIDE	Boiron	86d395ec-3c3b-5e5f-e053-2a91aa0a3f9c	2023-02-20		Exact identifier unii: ETJ7Z6XBU4
EyeClear Pro	CALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEA	Silver Star Brands	f4d4943b-cb78-aa71-e053-2a95a90ac638	2023-02-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
CellTropin	ARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUS	Micro Balance Health Products LLC	502d3ffa-bbf4-403a-9fad-b6b229f36a8c	2023-02-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	XLCare Pharmaceuticals, Inc.	51a27110-e787-409b-98ba-c6471d0ad5cf	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 966248 rxcui: 892251 rxcui: 966222 rxcui: 966270 rxcui: 892246 rxcui: 966221 rxcui: 892255 rxcui: 966224 rxcui: 966249 rxcui: 966220 rxcui: 966225 rxcui: 966253 unii: 9J765S329G
Saccharum Officinale	SACCHARUM OFFICINALE	Hahnemann Laboratories, INC.	f04b0ab3-af1c-ec2d-e053-2995a90a7855	2023-01-27		Exact identifier unii: C151H8M554
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Camber Pharmaceuticals, Inc.	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	2023-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 966248 rxcui: 892251 rxcui: 966222 rxcui: 966270 rxcui: 892246 rxcui: 966221 rxcui: 892255 rxcui: 966224 rxcui: 966249 rxcui: 966220 rxcui: 966225 rxcui: 966253 unii: 9J765S329G
Silicea	SILICON DIOXIDE	Boiron	86d2db09-9c46-37f7-e053-2a91aa0a326f	2023-01-23		Exact identifier unii: ETJ7Z6XBU4
Silicea	SILICON DIOXIDE	Boiron	86d3be33-b50e-e649-e053-2a91aa0acfc5	2023-01-23		Exact identifier unii: ETJ7Z6XBU4
Silicea	SILICON DIOXIDE	Boiron	86d3be33-b4fb-e649-e053-2a91aa0acfc5	2023-01-23		Exact identifier unii: ETJ7Z6XBU4
Gyno Complex	VIBURNUM OPULUS, MAGNESIA PHOSPHORICA, FOLLICULINUM, PULSATILLA (PRATENSIS), BORAX, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALIS	Deseret Biologicals, Inc	dfaaa56a-4226-4f62-a219-d3f89fe7afe3	2023-01-12	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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