FDA.reportPublic FDA data

NDC 80425-0282-01 - Baclofen

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
80425-0282
Requested NDC
80425-0282-01
Package NDCs from labels
80425-0282-2, 80425-0282-1, 80425-0282-3, 80425-0282-4, 80425-0282-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-11-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0282-1Baclofen30 in 1 BOTTLETABLET302
80425-0282-2Baclofen60 in 1 BOTTLETABLET602
80425-0282-3Baclofen90 in 1 BOTTLETABLET902
80425-0282-4Baclofen120 in 1 BOTTLETABLET1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0282BACLOFEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 4 package rows20241116_f5edb656-4f7e-2386-e053-2995a90a70de.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0282-1EA - Each80425-02826dc60c48-2657-425f-bc48-f4f28897157712023-04-07
80425-0282-2EA - Each80425-028242f8d368-b537-40b6-9557-e8544b27c1ca12023-04-07
80425-0282-3EA - Each80425-0282b6333d87-6abb-4774-9644-0242ac576cf112023-04-07
80425-0282-4EA - Each80425-0282f179f3fc-b772-4532-8048-9a3dba92b73c12024-12-10

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 5 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACLOFENBACLOFENAdvagen Pharma Ltd2a43830f-a28b-ca15-e063-6294a90a6b1a2025-06-12Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENHAWAII REPACK, INC.bc48a775-1feb-44c4-9453-e1ccf3d929bd2025-06-11Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAdvagen Pharma Ltd.,75ab298b-b2a7-458f-accc-5bfc89b89a162025-06-11Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENAurobindo Pharma Limited4679a275-9307-4b0f-a2eb-2d83227ea84d2025-06-11Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENSagent Pharmaceuticalsd4bfba33-9f4d-4c43-ae6c-bcf67ef8fe512025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENProficient Rx LP0243dd97-1d40-48f7-8853-76e046c605f22025-04-01Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack8cb96e7b-9c40-46a9-b964-7a573b7a03422025-02-21Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENXLCare Pharmaceuticals Inc.2b4908fb-47b5-4675-be9e-ca1ad48a72522025-02-05Warnings, Adverse reactionsExact identifier
application number: ANDA212378
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENNuCare Pharmaceuticals,Inc.fd00fa8f-2797-c3f0-e053-6294a90a975f2025-02-05Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENAdvanced Rx of Tennessee, LLC2cf71f5f-6d46-7506-e063-6294a90a186f2025-01-30Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENDirect_Rx020632f4-5e8a-f4a0-e063-6294a90a63012025-01-28Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack4b215bc5-f7f9-4b39-b8ee-42b233ee4aa22025-01-22Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack9bbcbf20-57ed-447b-9744-a5f10b9a057a2025-01-22Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENAsclemed USA, Inc.687f48da-bc41-4700-9513-77a32fc86c932025-01-15Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENNexus Pharmaceuticals LLC68c9ade0-d783-43e9-8a3f-a16ec1501ec12025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx of Tennessee, LLCb33c534d-4fa3-0a2f-e053-2995a90ab52f2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx of Tennessee, LLCb33c4164-e607-2e27-e053-2a95a90ad7db2024-12-31Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCb4f2f888-979a-6f54-e053-2a95a90a95a32024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCc85a1884-f46f-5cd4-e053-2a95a90a3e272024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA212378
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCc85a9d82-1d61-aeec-e053-2995a90a03a42024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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