FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Tizanidine - Bryant Ranch PrepackBryant Ranch Prepack2026-02-04HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2025-10-09HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2025-10-09HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-05-02HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Direct_rxDirect_rx2025-02-03HUMAN PRESCRIPTION DRUG LABEL
Tizanidine HCL - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - AvKAREAvKARE2024-01-10HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Bryant Ranch PrepackBryant Ranch Prepack2023-12-07HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Bryant Ranch PrepackBryant Ranch Prepack2023-11-29HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Bryant Ranch PrepackBryant Ranch Prepack2023-11-09HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - REMEDYREPACK INC.REMEDYREPACK INC.2023-04-19HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - NCS HealthCare of KY, LLC dba Vangard LabsNCS HealthCare of KY, LLC dba Vangard Labs2023-02-24HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Proficient Rx LPProficient Rx LP2022-03-01HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2021-09-21HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - A-S Medication SolutionsA-S Medication Solutions2021-03-01HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2021-01-04HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Sun Pharmaceutical Industries, Inc. | ALKALOIDA chemical company ZrtSun Pharmaceutical Industries, Inc. | ALKALOIDA chemical company Zrt2020-10-09HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Major PharmaceuticalsMajor Pharmaceuticals2019-06-05HUMAN PRESCRIPTION DRUG LABEL
Tizanidine - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2016-12-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-503-18Tizanidine1000 in 1 BOTTLETABLET10009
57664-503-89Tizanidine150 in 1 BOTTLETABLET1509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-503TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 2 package rows20201010_4659df31-8b89-4eff-9d86-7b7e38de416b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-503-13EA - Each57664-50359c52ed5-491e-40c4-ac95-b8ece7f27eb112012-07-24
57664-503-18EA - Each57664-503a018f0c4-88ae-4fd7-b1ba-40f719e56f0212012-07-24
57664-503-83EA - Each57664-503a478ffde-beef-44f3-ac09-bcc953752dc112012-07-24
57664-503-88EA - Each57664-503bf01783f-a12a-4fc3-a1d2-0e8f21c7f2ef12012-07-24
57664-503-89EA - Each57664-5036ad6f4c9-2594-4909-b656-38d0eaf517b612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [AVKARE, INC.]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [AVKARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [AVKARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [AVKARE, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [AVKARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTIZANIDINE TABLET [AVKARE, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE 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 8 of 37 · 734 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd487c5036-0eb0-ada9-e063-6394a90aa02e2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD487cd5b9-28f3-392d-e063-6394a90a9ba12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd487cf27a-d761-6353-e063-6394a90af0292026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd487d52d1-8853-bc90-e063-6394a90ab91d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD487d689d-ebdd-43c3-e063-6294a90af0e22026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD487da363-1d01-8cdc-e063-6294a90ac24d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Berberis QuartzBERBERIS QUARTZUriel Pharmacy Inc.5da48d70-1140-495d-b672-0e55c04196e12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
4875af35-46c8-d9e6-e063-6394a90ab93d150c131c-3dc5-8417-2dc0-d0d440fb1d342026-01-15Warnings, Adverse reactionsExact identifier
spl set id: 150c131c-3dc5-8417-2dc0-d0d440fb1d34
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Amber AmethystAMBER AMETHYSTUriel Pharmacy, Inc4837e805-a777-c1fa-e063-6294a90ae9c42026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
ECHINACEAECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUSMarco Pharma International LLC.7efadb70-99e4-428b-a8ef-a2797327c6fa2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
TizanidineTIZANIDINEAvPAKb694225c-1fa9-4726-89a6-fd3f870842482026-01-11Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Organophosphate Combination 9309ORGANOPHOSPHATE COMBINATIONProfessional Complementary Health Formulasf777015f-1df6-4821-af63-543175313aba2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Low Vaccinosis Nosode 4024LOW VACCINOSIS NOSODEProfessional Complementary Health Formulasf347ac8f-ac05-46ef-91a3-9f7e000347682026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Second Chakra (Sacral) 7302SECOND CHAKRA (SACRAL)Professional Complementary Health Formulasea8a69d3-66fc-4b21-bfdd-c207dd2935892026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 8012SILICEAProfessional Complementary Health Formulasa2a1eae8-24c8-44dd-9b9d-1826fa7164332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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