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 2 of 37 · 734 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hypothalmapath	GELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEA	Energetix Corporation	3c4e2867-4d75-416b-9f3d-e6e500e46f6f	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lipo-Chord	ACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.	Energetix Corporation	5c83cbd5-46fb-48a0-a739-ff9c81e7129c	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lymph-Tone II	AESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.	Energetix Corporation	c46aa8d3-4aa5-4e07-be3d-d71abc5e2407	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lymph-Tone III	ADENOSINUM CYCLOPHOSPHORICUM, ARNICA, BOLDO, CALC IOD, CALENDULA, CARTILAGO SUIS, CEANOTHUS, COENZYME A, ECHINACEA, HAMAMELIS, HEPAR SULPH CALC, HYPOTHALAMUS, NADIDUM, NAJA, NAT SULPHURICUM, PHASEOLUS, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PYROGENIUM, SILICEA, SULPHUR, THUJA OCC, THYROIDINUM, VISCUM	Energetix Corporation	4c9ae54c-ce7d-4276-add7-2922a8f0e310	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Metabopath	ADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,	Energetix Corporation	58bfe670-d308-45a2-8046-7897b6221452	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Vac-Chord	ALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.	Energetix Corporation	880ea1e6-8d4d-486e-9a8f-9d3158a99667	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tox-Chord	ALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.	Energetix Corporation	b06b4794-e5bb-4ccd-87fd-37afca7b0f98	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Thyro-Chord	HOMEOPATHIC LIQUID	Energetix Corporation	6655b504-dfa8-46df-9d3a-b7fa4078207e	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Chord	HOMEOPATHIC LIQUID	Energetix Corporation	9f8f646e-634a-47ff-b208-b2249d685e55	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
MycoCan-Chord	ALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUM	Energetix Corporation	227199f8-a45e-44ff-892d-ade4fefea354	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
ROROBELL WAWA Whitening Tooth	SILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE	ROROBELL	58336a0d-49dd-ef13-e063-6394a90a38c1	2026-08-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tizanidine	TIZANIDINE	Aphena Pharma Solutions - Tennessee, LLC	25db7cc0-604c-3d6b-e063-6394a90a337f	2026-08-04	Warnings, Adverse reactions	Exact identifier application number: ANDA076416 rxcui: 313413 unii: B53E3NMY5C
Silicea 6X	SILICON DIOXIDE	Hyland's Inc.	db4be3c1-aa7e-24a2-e053-2a95a90a0c66	2026-08-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Smogstat	ECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA	Energique, Inc.	59f63e2b-24fa-43a0-8334-02e6729c6ac1	2026-07-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Muscle Ice	PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)	Peaceful Mountain, Inc.	03b6e2a9-f335-4ae2-9011-80bd019afb72	2026-07-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Bioplasma	SILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDE	Hyland's Inc.	dd0a7ed2-d112-4b96-e053-2995a90ac6b6	2026-07-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tizanidine	TIZANIDINE	NuCare Pharmaceuticals,Inc.	6dd9946f-b2a4-1732-e053-2a91aa0a648f	2026-07-24	Warnings, Adverse reactions	Exact identifier rxcui: 313413 unii: B53E3NMY5C
Prid	ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR	Hyland's Inc.	49689eeb-7790-07f1-e063-6294a90a2df2	2026-07-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
tizanidine	TIZANIDINE	Preferred Pharmaceuticals Inc.	8d0b2b22-e1df-4ad5-92e6-f9a369108e4b	2026-07-16	Warnings, Adverse reactions	Exact identifier rxcui: 313413 unii: B53E3NMY5C
Leg Cramps PM	OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR	Hyland's Inc.	b0574a7e-88fa-417e-b6d5-60ced59eba47	2026-07-15	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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