FDA.reportPublic FDA data

NDC 68071-4463-09 - 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
68071-4463
Requested NDC
68071-4463-09
Package NDCs from labels
68071-4463-3, 68071-4463-6, 68071-4463-9, 68071-4463-09
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2026-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tizanidine - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2026-07-24HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-06-10These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996
2024-06-10These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996
2023-01-30These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996
2023-01-30These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996
2021-02-16These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996
2021-02-16These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996
2021-01-29These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996
2021-01-29These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4463-3Tizanidine30 in 1 BOTTLETABLET307
68071-4463-6Tizanidine60 in 1 BOTTLETABLET607

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 1 of 37 · 735 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
HeadacheMELILOTUS OFFICINALIS, SPIGELIA ANTHELMIA, ALLIUM CEPA, BELLADONNA, BRYONIA (ALBA), CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, SANGUINARIA CANADENSIS, SILICEA, TARENTULA CUBENSISBioActive Nutritionals, Inc.918bc478-78a2-41e1-b123-f5350cf8f43a2026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
TizanidineTIZANIDINENuCare Pharmaceuticals,Inc.6dd9946f-b2a4-1732-e053-2a91aa0a648f2026-07-24Warnings, Adverse reactionsExact identifier
application number: ANDA091283
ndc (package): 68071-4463-3
ndc (package): 68071-4463-9
ndc (package): 68071-4463-6
ndc (product): 68071-4463
ndc11 (package): 68071446309
rxcui: 313413
spl id: 575e647c-cdad-794c-e063-6394a90a196b
spl set id: 6dd9946f-b2a4-1732-e053-2a91aa0a648f
unii: B53E3NMY5C
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
tizanidineTIZANIDINEPreferred Pharmaceuticals Inc.8d0b2b22-e1df-4ad5-92e6-f9a369108e4b2026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack649f1f76-da33-4bdf-a38d-5ae3a9cb79872026-07-09Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEREMEDYREPACK INC.b14bd166-9f53-4f2e-be05-c447af04ef692026-07-08Warnings, Adverse reactionsExact identifier
application number: ANDA091283
rxcui: 313413
unii: B53E3NMY5C
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
TizanidineTIZANIDINEHAWAII REPACK, INC.45de30ce-959f-4e2e-a974-6f90568139c92026-06-25Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEREMEDYREPACK INC.59084f59-9a9b-49f0-a9f4-27f3eab9a2282026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINERedpharm Drug54ade0c7-4bf0-54d4-e063-6294a90a8b172026-06-20Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINESt. Mary's Medical Park Pharmacyc6b4486f-e847-64ee-e053-2995a90a855a2026-06-19Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEDirect_Rx5460dbf8-b30d-db94-e063-6394a90a55532026-06-16Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
TizanidineTIZANIDINESt. Mary's Medical Park Pharmacycfd52c0c-a7c2-e23d-e053-2a95a90abbd12026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 313412
unii: B53E3NMY5C