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 7 of 37 · 734 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quantum Harmony	BLATTA AMERICANA, CEREBRUM SUIS, CACAO, COLUMBUS PALUMBA, HEART (SUIS), DIOSPYROS KAKI, FORMICA RUFA, HYPOTHALAMUS SUIS, HYPOPHYSIS SUIS, PALOONDO, NPY (NEUROPEPTIDE Y), SEROTONIN (HYDROCHLORIDE), SILICEA, SULPHUR, VERATRUM ALBUM, SALIX VITELLINA, FLOS	Deseret Biologicals, Inc.	1742ac50-ec6e-4261-a0b8-791b893742ef	2026-02-25	Warnings	Exact identifier unii: ETJ7Z6XBU4
Outdoor Allergies	ACONITUM NAPELLUS, ADRENALINUM, ALLIUM CEPA, RAGWEED POLLEN, ARSENICUM IODATUM, MUGWORT POLLEN, MUSTARD POLLEN, LAMBS QUARTERS POLLEN, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, PERENNIAL RYE GRASS POLLEN, ALFALFA POLLEN, TIMOTHY GRASS POLLEN, YELLOW DOCK POLLEN, SABADILLA, SILICEA, DANDELION POLLEN, RED CLOVER POLLEN, COCKLEBUR POLLEN	NaturalCare	b0a76faa-a081-4cee-ae40-e5605458bec3	2026-02-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BIO28 (General Tonic)	CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA	BM Private Limited	38d2cff0-3550-b119-e063-6394a90a31cb	2026-02-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
Allergy Maximum Strength	URTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	122ca23e-43f1-4e5c-afc2-1418b1717679	2026-02-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Mitochondria Pro	ARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,	Energique, Inc.	2f365207-b730-428d-9465-8853e86e79ff	2026-02-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
BIO COM 25 ACIDITY	NAT PHOS, NAT SULPH, SILICEA	BM Private Limited	3b3c3455-b321-071d-e063-6394a90a0160	2026-02-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
CINA	AMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEA	BM PRIVATE LIMITED	3b3c0874-90b5-deda-e063-6394a90a7802	2026-02-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
Acne/Pimple Control	CALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDE	Forces of Nature	e871e46e-463e-49ec-a2af-5aa98548ee12	2026-02-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tizanidine	TIZANIDINE	A-S Medication Solutions	308d2fdc-6136-4e75-95d3-342497add66c	2026-02-13	Warnings, Adverse reactions	Exact identifier rxcui: 313413 unii: B53E3NMY5C
Fuligo	CIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEA	BM Private Limited	3b27225f-4587-d915-e063-6294a90a7225	2026-02-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tizanidine	TIZANIDINE	A-S Medication Solutions	9fd932fb-033c-4774-ac09-c823db8f9739	2026-02-12	Warnings, Adverse reactions	Exact identifier rxcui: 313413 unii: B53E3NMY5C
Mold, Yeast and Dust	ADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEA	NaturalCare	32afa0f0-bca5-4246-bc2e-decd757fcf9d	2026-02-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
DPT-TOX	DROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJA	Nutrition Center Inc dba Nutri-West dba Micro-West	5e39f4e6-939f-4b71-9cc5-6d4b8711ea32	2026-02-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	fefe8332-32eb-4b81-978f-b23b334d7d57	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: ANDA076416 ndc (package): 71335-3016-1 ndc (package): 71335-3016-2 ndc (product): 71335-3016 rxcui: 313413 spl id: f722dde4-55ee-44f4-9d1a-07214c62cd83 spl set id: fefe8332-32eb-4b81-978f-b23b334d7d57 unii: B53E3NMY5C
Meteoric Iron Prunus	METEORIC IRON PRUNUS	Uriel Pharmacy Inc.	e9020757-2393-4a22-9665-25da0a0993d0	2026-02-03	Warnings	Exact identifier unii: ETJ7Z6XBU4
Mold, Yeast and Dust	ACREMONIUM STRICTUM, ADRENALINUM, ALLIUM CEPA, ALTERNARIA ALTERNATA, ARSENICUM IODATUM, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, CANDIDA ALBICANS, CLADOSPORIUM HERBARUM, COCKROACH, DERMATOPHAGOIDES FARINAE, EPICOCCUM PURPURASCENS, FUSARIUM SOLANI, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR CIRCINELLOIDES, NATRUM SULPHURICUM, RHIZOPUS STOLONIFER, SACCHAROMYCES CEREVISIAE, SILICEA	NaturalCare	e0f53f47-acd9-43e2-a7a2-2a500bc9dc1b	2026-02-03	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tizanidine	TIZANIDINE	Redpharm Drug	49adcfc8-3b1d-7f7e-e063-6294a90a361e	2026-01-31	Warnings, Adverse reactions	Exact identifier rxcui: 313412 unii: B53E3NMY5C
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3f569c5a-ec9d-4356-ac04-c17714ff68d1	2026-01-23	Warnings, Adverse reactions	Exact identifier unii: B53E3NMY5C
BioMicroneedle PDRN Cream	SILICON DIOXIDE	Guangzhou Shengyanghui Industrial Trading Co., Ltd	48e2edae-94ea-c42e-e063-6394a90a907b	2026-01-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ebccdb33-2b3c-4071-9765-8d95bcbc9b5f	2026-01-21	Warnings, Adverse reactions	Exact identifier unii: B53E3NMY5C

Reported adverse events (FAERS/openFDA)#

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