FDA.reportPublic FDA data

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 9 of 60 · 1,184 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.0a1d09ac-94d5-45ef-92cc-bc261c2b2d752026-03-25Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Reflux AwayABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICANaturalCare8a00a72f-60df-4477-b7b8-abb6355e34da2026-03-24WarningsExact identifier
unii: 451W47IQ8X
BaclofenBACLOFENA-S Medication Solutions4f84b27a-725a-48e6-a58a-85bbb395f4ae2026-03-23Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Worafy Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4da864dc-e10c-1db9-e063-6394a90a09842026-03-22WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
BACLOFENBACLOFENPreferred Pharmaceuticals Inc.d20cc8b2-5236-4c87-b395-0acaaf7b62dd2026-03-19Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENA-S Medication Solutions5f6a86f9-9658-4210-a47c-62907edfd4162026-03-19Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACLOFENBACLOFENPreferred Pharmaceuticals Inc.5e479876-adfb-4590-ac10-3924ff7988b02026-03-18Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENPreferred Pharmaceuticals Inc.3fdfeef9-68b3-4f6c-a4de-28179758a9622026-03-18Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
unii: 451W47IQ8X
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 451W47IQ8X
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b812c9-fb0a-5ee0-e063-6294a90a03e12026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b88e7c-eca0-5540-e063-6294a90a1b182026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b8c3f4-e528-c69d-e063-6294a90a5a342026-03-16WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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