NDC 57664-503-83 - Tizanidine

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: 57664-503
Requested NDC: 57664-503-83
Package NDCs from labels: 57664-503-89, 57664-503-18, 57664-503-83
Manufacturer: Bryant Ranch Prepack
Effective date: 2026-02-04
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Tizanidine - Bryant Ranch Prepack	Bryant Ranch Prepack	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Northwind Health Company, LLC	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-05-02	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Direct_rx	Direct_rx	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine HCL - Advanced Rx of Tennessee, LLC	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - AvKARE	AvKARE	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Bryant Ranch Prepack	Bryant Ranch Prepack	2023-12-07	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Bryant Ranch Prepack	Bryant Ranch Prepack	2023-11-29	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Bryant Ranch Prepack	Bryant Ranch Prepack	2023-11-09	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - REMEDYREPACK INC.	REMEDYREPACK INC.	2023-04-19	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - NCS HealthCare of KY, LLC dba Vangard Labs	NCS HealthCare of KY, LLC dba Vangard Labs	2023-02-24	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Proficient Rx LP	Proficient Rx LP	2022-03-01	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2021-09-21	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - A-S Medication Solutions	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-04	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Sun Pharmaceutical Industries, Inc. \| ALKALOIDA chemical company Zrt	Sun Pharmaceutical Industries, Inc. \| ALKALOIDA chemical company Zrt	2020-10-09	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Major Pharmaceuticals	Major Pharmaceuticals	2019-06-05	HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Aidarex Pharmaceuticals LLC	Aidarex Pharmaceuticals LLC	2016-12-09	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
57664-503-18	Tizanidine	1000 in 1 BOTTLE	TABLET	1000		9
57664-503-89	Tizanidine	150 in 1 BOTTLE	TABLET	150		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-503	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20201010_4659df31-8b89-4eff-9d86-7b7e38de416b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-503-13	EA - Each	57664-503	59c52ed5-491e-40c4-ac95-b8ece7f27eb1	1	2012-07-24
57664-503-18	EA - Each	57664-503	a018f0c4-88ae-4fd7-b1ba-40f719e56f02	1	2012-07-24
57664-503-83	EA - Each	57664-503	a478ffde-beef-44f3-ac09-bcc953752dc1	1	2012-07-24
57664-503-88	EA - Each	57664-503	bf01783f-a12a-4fc3-a1d2-0e8f21c7f2ef	1	2012-07-24
57664-503-89	EA - Each	57664-503	6ad6f4c9-2594-4909-b656-38d0eaf517b6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [AVKARE, INC.]	2
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [AVKARE, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [AVKARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [AVKARE, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [AVKARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TIZANIDINE TABLET [AVKARE, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [AVKARE, INC.]	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 5 of 37 · 734 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Age Defiance Pro	7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONE	Energique, Inc.	d528bdbe-fb75-4b13-9cbc-efa2177d74d8	2026-05-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Pollen Hayfever	ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUM	NaturalCare	00665933-176e-4f16-b6ee-b55217b8abb3	2026-05-05	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydrate I	COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA	BioActive Nutritional, Inc.	c0c8d350-0257-4484-acd8-f852350173db	2026-04-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tizanidine	TIZANIDINE	Medcore LLC	14bcfbac-8f6a-42af-b3a4-ba10d99f2468	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: ANDA076416 rxcui: 313412 rxcui: 313413 unii: B53E3NMY5C
Dentastat	ALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUM	Energique, Inc.	7f6d360b-9fee-4374-a47c-847806d54fa0	2026-04-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Animal Hair and Dander	ADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEA	NaturalCare	f0067255-9310-43a0-b415-c03a0f554bcc	2026-04-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Quantum Resonance	ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM	Deseret Biologicals, Inc.	f94a10bd-1c40-42c7-b458-b58070614549	2026-04-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Quantum Resonance	ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM	Deseret Biologicals, Inc.	1467111a-bef6-473d-b7f2-3309a9bb72ce	2026-04-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Kanchan Healthcare Inc	22ea819a-2aaa-44e0-a350-258541b11220	2026-04-08	Warnings, Adverse reactions	Exact identifier unii: B53E3NMY5C
H-Focus Formula	AGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUM	Healing Natural Oils LLC	4ee42911-3064-7f55-e063-6294a90abcc7	2026-04-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
H-Mood Formula	AGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUM	Healing Natural Oils LLC	4ee5c82e-9edf-c36e-e063-6394a90a237f	2026-04-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	f041e5f7-c138-4622-98bf-881f9a649a26	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: ANDA076416 rxcui: 313412 unii: B53E3NMY5C
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	7bbc81e5-ad3e-496b-908f-e6f500f6ad7e	2026-04-03	Warnings, Adverse reactions	Exact identifier rxcui: 313412 unii: B53E3NMY5C
Sinus Defense	LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE	Micro Balance Health Products LLC	9c2f51c5-aa41-414e-a966-32e02e9e79a2	2026-04-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
Acne HP	CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM	BioActive Nutritional, Inc.	2ab4ff53-4274-40c7-b05c-44d918d809be	2026-03-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lymphoplex	MYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEA	BioActive Nutritional, Inc.	624f35db-291e-4e7f-a2c9-ae319717157a	2026-03-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Equisetum Silicea	EQUISETUM SILICEA	Uriel Pharmacy Inc.	e88b820b-4a07-42e2-8fe2-b30729e91a8c	2026-03-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
B Force HP	APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA	BioActive Nutritional, Inc.	811c6f32-fcad-464c-bcf6-ae6a59195b1c	2026-03-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lymphdrainex	GERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,	Energique, Inc.	c512f211-f4f8-46f6-87ed-dd50287359df	2026-03-27	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	31b40276-099b-482c-a13c-8fbbf1ebc50a	2026-03-25	Warnings, Adverse reactions	Exact identifier unii: B53E3NMY5C

Reported adverse events (FAERS/openFDA)#

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