FDA.reportPublic FDA data

NDC 61919-221-90 - 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
61919-221
Requested NDC
61919-221-90
Package NDCs from labels
61919-221-15, 61919-221-86, 61919-221-30, 61919-221-60, 61919-221-90, 61919-221-72
Manufacturer
Direct_Rx
Effective date
2022-10-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TIZANIDINE - Direct_RxDirect_Rx2022-10-11HUMAN PRESCRIPTION DRUG LABEL
TIZANIDINE - Direct_RxDirect_Rx2022-09-30HUMAN PRESCRIPTION DRUG LABEL
TIZANIDINE - Direct RxDirect Rx2015-11-05HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-221-722020-01-31C16284748780-19d75b9d0-7aad-f424-e053-dadaa90a57ceTIZANIDINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-221-30TIZANIDINE30 in 1 BOTTLETABLET302
61919-221-60TIZANIDINE60 in 1 BOTTLETABLET602
61919-221-72TIZANIDINE120 in 1 BOTTLETABLET1202
61919-221-90TIZANIDINE90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-221TIZANIDINE TABLET [DIRECT RX]2Legacy NDC, 4 package rows20151106_54bd58ee-76f6-44e7-83bb-fe752c3cbf9a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-221-15EA - Each61919-221215117cd-08bd-4a81-adc0-138a7beb7df112019-10-07
61919-221-30EA - Each61919-2212f58fb4b-1857-4b5d-b1a2-21b1f5adfca412014-07-02
61919-221-60EA - Each61919-2215dfe56f5-ffbc-4a49-a4e1-0df0d9c16dd612014-10-03
61919-221-72EA - Each61919-221f104c843-417f-4436-9227-e72cfdfefc6312014-07-02
61919-221-86EA - Each61919-2210fbd2fee-4a39-458c-a7ac-9926c6f60a1d12019-09-05
61919-221-90EA - Each61919-2218080cee6-a39a-4bc1-9868-cb20d50852f712014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [DIRECT RX]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [DIRECT RX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [DIRECT RX]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [DIRECT RX]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 1 of 38 · 741 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
TIZANIDINETIZANIDINEAurobindo Pharma Limited7ce17c02-7f1f-4d52-8b6f-52e385e122392026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
tizanidineTIZANIDINEREMEDYREPACK INC.63b7eba3-6dea-4d89-bc42-7e965ae9795d2026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
TizanidineTIZANIDINERedpharm Drug59d83e3a-5e44-d8d0-e063-6294a90aa65a2026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 313412
unii: B53E3NMY5C
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
TizanidineTIZANIDINEREMEDYREPACK INC.9bcc7f09-d2b5-4602-aaf3-5410b55ce2752026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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