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 8 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENA-S Medication Solutionse163e7dc-45a5-43c2-b13d-a4453f2c360c2023-12-05Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENA-S Medication Solutions081d478a-2f3f-456e-bcca-00487589da6f2023-12-05Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Baclofen (Intrathecal)BACLOFENMAIA Pharmaceuticals, Inc.11ba5575-a856-414a-89f8-17f3a01de55b2023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack58816b46-28a5-48e2-b89d-98df659393862023-10-20Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack9110b1cb-8604-4824-9337-84b08d41dd3c2023-10-20Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepackf9cf294a-85d1-4321-af68-4279b20c4b712023-10-19Warnings, Adverse reactionsExact identifier
application number: ANDA212378
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepackfded79a4-c354-448d-96dd-6dc69c46a0132023-10-19Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack2cd15814-5f70-4c65-9f43-367495486ecd2023-10-18Warnings, Adverse reactionsExact identifier
application number: ANDA212378
unii: H789N3FKE8
BaclofenBACLOFENTRUPHARMA, LLCf8ec79c6-da65-4fb6-b6bd-45df0d2a52c72023-10-18Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack7ed13ef7-329e-40cb-b9b1-31a4bf32ac982023-08-29Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENBryant Ranch Prepack96f9caa3-0d36-4d99-8c6f-0da5b0d035272023-08-11Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENSlayback Pharma LLC9fad5ffc-afae-4c92-a672-ee636df45bc52023-06-16Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENUnichem Pharmaceuticals (USA), Inc.b9199878-3fb4-46dc-adbb-b3d9dc3852d42023-06-08Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENNCS HealthCare of KY, LLC dba Vangard Labs2927228a-7a3e-4e1d-ab5f-4407b00f68992023-05-31Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
LYVISPAHBACLOFENAmneal Pharmaceuticals LLCf8992a56-9010-4c4b-84d5-ddcc3e2c33172023-04-23Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENMAlA Pharmaceuticals, Inc.e05080ef-53d9-4060-aaa4-86a6935467de2023-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENMAlA Pharmaceuticals, Inc.dfa6148c-693c-45f1-89be-0e77d39f313e2023-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Lioresal (baclofen)BACLOFENAmneal Pharmaceuticals LLC6f3bdcc0-ffc8-4911-8c35-958c8103a2c52022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCedef7819-875f-4855-8f1f-32407f82e9dc2022-09-08Warnings, Adverse reactionsExact identifier
application number: ANDA212378
unii: H789N3FKE8
BaclofenBACLOFENProficient Rx LPb65d3089-0412-487f-a1b4-66f0bc6f398e2022-03-01Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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