FDA.reportPublic FDA data

Tabradol

Manufacturer
Fusion Pharmaceuticals LLC
Effective date
2016-01-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 20:21:49

Label at a glance#

ProductTabradol
Active ingredientCYCLOBENZAPRINE HYDROCHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

Suspension Label

DESCRIPTION SECTION

Structured Suspension VehicleStructured Suspension Vehicle

Flavor Label

DESCRIPTION SECTION

Structured Flavor vehicle labelStructured Flavor vehicle label

Instructions Insert

DESCRIPTION SECTION


InstructionsInstructions

Instructions

INSTRUCTIONS FOR USE SECTION

InstructiondInstructiond

Instructions

INSTRUCTIONS FOR USE SECTION

InstructionsInstructions

Cyclobenzaprine drug Label

DESCRIPTION SECTION

Cyclobenzaprine labelCyclobenzaprine label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CYCLOBENZAPRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43093-101-012020-01-31C16284748780-19d75b9d0-544c-f424-e053-dadaa90a57ceTABRADOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43093-101-01Tabradol1 in 1 KITKIT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43093-101TABRADOL (CYCLOBENZAPRINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]9Legacy NDC, 1 package rows20160108_5d19ef8b-eef3-4d52-95f5-929765ca6dc7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43093-101-01ML - Milliliter43093-101b835bb30-950b-4a7a-9a85-3c48caecfd2e12015-10-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43093-10143093-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOBENZAPRINE HYDROCHLORIDE0VE05JYS2PACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CHERRYBUC5I9595WIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM CITRATE1Q73Q2JULRIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
28c7b9e3-07ca-6f9b-e054-00144ff88e885d19ef8b-eef3-4d52-95f5-929765ca6dc72016-01-07Exact identifier
spl id: 28c7b9e3-07ca-6f9b-e054-00144ff88e88
spl set id: 5d19ef8b-eef3-4d52-95f5-929765ca6dc7

Reported adverse events (FAERS/openFDA)#

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