NDC 71525-005-01 - Baclofen (intrathecal)

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
71525-005
Requested NDC
71525-005-01
Package NDCs from labels
71525-005-01, 71525-005-10
Manufacturer
Emerald International Limited
Effective date
2018-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen (intrathecal) - Emerald International LimitedEmerald International Limited2018-03-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71525-005-102023-01-30C16284748780-1f386c64a-087e-0266-e053-dadaa90a7c1aBaclofen Injection (Intrathecal)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71525-005-01Baclofen (intrathecal)1 mL in 1 AMPULEINJECTION12
71525-005-10Baclofen (intrathecal)10 in 1 BOXINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71525-005BACLOFEN (INTRATHECAL) (BACLOFEN) INJECTION [EMERALD INTERNATIONAL LIMITED]2Legacy NDC, 2 package rows20181201_63c13374-f4d1-4437-a703-acb8211f2ae4.zip

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 56 of 57 · 1,134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENTeva Pharmaceuticals USA, Inc.5648c772-50cb-4961-996e-e68a8eb699ea2019-12-31Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plasma-Lyte ASODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEBaxter Healthcare Corporation6ec9e61c-2c26-402f-8604-f446b2e340582019-08-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChloridePOTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBaxter Healthcare Companyc553fed1-3de5-4826-8eff-633b5923bf0b2019-02-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChloridePOTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Companybecc7410-0a25-49f5-b0c3-240078479dc82019-01-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Skin Klear Acne ReliefTRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLORHomeocare Laboratories65afbc20-611b-4bc4-a151-c633bec66a822018-12-31WarningsExact identifier
unii: 451W47IQ8X
H.M.D.ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOMZorex International8c53091a-904d-4756-93e4-17143c5b48e92018-12-21WarningsExact identifier
unii: 451W47IQ8X
Vitality FemaleARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIANatural Creations, Inc679ba86d-bf84-4ded-b0bf-d55a0df9faa42018-12-21WarningsExact identifier
unii: 451W47IQ8X
Hydrate IIBERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUAZorex Internationale5f53495-3b75-4d7c-89af-23058fb6fd052018-12-21WarningsExact identifier
unii: 451W47IQ8X
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
WinCo Foods Saline Nasal ReliefSODIUM CHLORIDEWinCo Foods, LLC1280fee4-e763-49ba-8722-8cdb8157f1a42018-08-02WarningsExact identifier
unii: 451W47IQ8X
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation05dee566-7b82-4216-8a6b-765d2b4d9dc72018-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: 451W47IQ8X
Metabolic SupportFUCUS VESICULOSUS, AGNUS CASTUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHYTOLACCA DECANDRA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, CARBO VEGETABILIS, GRAPHITES, CALCAREA CARBONICA, NATRUM PHOSPHORICUM, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, THYROIDINUM (SUIS)BodyLogicMD of Fort Lauderdalec2a1bd6d-c595-402f-a3bc-23f64c949d782018-06-08WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation181705c7-40e4-4d7d-b9ea-ada99380e7a92018-05-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation7c72520e-de3c-493d-8aea-11933376d9682018-04-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
66d85337-b4ad-403e-8631-3123311477b763c13374-f4d1-4437-a703-acb8211f2ae42018-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 66d85337-b4ad-403e-8631-3123311477b7
spl set id: 63c13374-f4d1-4437-a703-acb8211f2ae4
Lactated RingersSODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDEBaxter Healthcare Company5215ec33-8cfe-4885-ae92-e6a12100bd272018-01-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCdd4b9972-0295-4555-a90b-bb087170cfbb2017-12-07Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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