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 6 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCec09736a-dd2b-0a3b-e053-2995a90a95422024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA212378
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENAdvanced Rx of Tennessee, LLC2a58145a-57f9-6bb1-e063-6294a90a32a82024-12-29Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENAdvanced Rx of Tennessee, LLC2a586399-49e9-1e5c-e063-6294a90a48722024-12-28Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx of Tennessee, LLC29987a4c-cf5f-4f98-e063-6394a90a7f192024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENQuality Care Products, LLC67df80a6-7fff-496e-9a89-d43a06c2a11f2024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack7b6d33d8-58c2-448d-a8df-1de7339b15202024-12-12Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack4cbb2264-ef65-4906-86e5-349deeeda7a92024-12-05Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack32525b4e-6384-49e1-a66d-abe45484ab862024-12-05Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepacke13c0563-0f32-4199-acb0-ad2376ec951b2024-12-05Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack43cafbdb-6927-45f6-9b16-3b125cc2a29d2024-11-27Warnings, Adverse reactionsExact identifier
application number: ANDA212378
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCf5edb656-4f7e-2386-e053-2995a90a70de2024-11-15Warnings, Adverse reactionsExact identifier
application number: ANDA212378
ndc (package): 80425-0282-4
ndc (package): 80425-0282-3
ndc (package): 80425-0282-2
ndc (package): 80425-0282-1
ndc (product): 80425-0282
ndc11 (package): 80425028201
rxcui: 197392
spl id: 26f8bbf8-7c53-4c19-e063-6394a90a5a4a
spl set id: f5edb656-4f7e-2386-e053-2995a90a70de
unii: H789N3FKE8
BaclofenBACLOFENChartwell RX, LLC2a75db96-590a-43cf-aefb-3bbcb287dbf02024-10-10Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENNCS HealthCare of KY, LLC dba Vangard Labsea4ad5c5-207c-4a68-8e6e-4ff101777e5c2024-10-04Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENProficient Rx LPb981eb16-a195-41da-a186-3e91b63b2def2024-10-01Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENProficient Rx LP9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc2024-10-01Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENBryant Ranch Prepackf9c6d75a-a956-47b6-a5a2-deaf9797e2b22024-09-16Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack08a6866f-b127-482f-9f22-113175487bdd2024-09-12Warnings, Adverse reactionsExact identifier
application number: ANDA212378
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack5b92b0a6-ebba-4815-8b94-f2014674399b2024-09-05Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack4634093b-6def-41d6-a7f3-23040125c4f42024-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA212378
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack655db2a3-daf7-4f4b-8f64-4a6d81fdc1652024-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA212378
rxcui: 197392
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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