FDA.reportPublic FDA data

NDC 72162-2374-01 - 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
72162-2374
Requested NDC
72162-2374-01
Package NDCs from labels
72162-2374-0, 72162-2374-1, 72162-2374-2, 72162-2374-6, 72162-2374-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-09-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - Bryant Ranch PrepackBryant Ranch Prepack2024-09-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2374-0Baclofen1000 in 1 BOTTLETABLET1000101
72162-2374-1Baclofen100 in 1 BOTTLETABLET100101
72162-2374-2Baclofen120 in 1 BOTTLETABLET120101
72162-2374-6Baclofen60 in 1 BOTTLETABLET60101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2374BACLOFEN TABLET [BRYANT RANCH PREPACK]101Current NDC, 4 package rows20240905_655db2a3-daf7-4f4b-8f64-4a6d81fdc165.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2374-0EA - Each72162-23740dd13406-bc6b-4fbc-8c9f-b50fa0453b4212024-08-12
72162-2374-1EA - Each72162-2374af584e52-ee15-4e41-87e0-01727c80b66712024-08-12
72162-2374-2EA - Each72162-2374ae4cbfd1-bcf6-4298-9506-66f57e999de912024-08-12
72162-2374-6EA - Each72162-2374e477808e-6cc4-46f4-a9bd-2e527a8e412412024-08-12

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 4 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENBryant Ranch Prepack8a39dbc7-99d7-49e4-b5a1-cf70e7d753b22025-11-12Warnings, Adverse reactionsExact identifier
application number: ANDA212378
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENNorthstar RxLLC0aac77fa-30c2-46c8-a04d-e6b8333ddd812025-11-05Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENMajor Pharmaceuticalsf328296e-0713-4acb-bcb5-c10d7838d3802025-10-29Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENPD-Rx Pharmaceuticals, Inc.95755a7b-4a9f-45ea-a381-d3f661150efe2025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENPD-Rx Pharmaceuticals, Inc.cfcf519f-5d15-431d-89c8-961a0c38ba602025-10-17Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.5cba5255-e5ad-48fd-8385-60e9ea6b64072025-10-09Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack0a5940cd-63eb-4d1b-8e92-44df264bc05a2025-10-03Warnings, Adverse reactionsExact identifier
application number: ANDA212378
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepackab5fd609-3081-4400-90cd-c83b6834d3812025-10-03Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENMarlex Pharmaceuticals Inc1b0f50c8-62e3-414d-96d3-5fd16e8043ab2025-09-22Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENBryant Ranch Prepack844a09ab-6c11-44fa-a09b-09e2b7a3759e2025-08-25Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENAsclemed USA, Inc.35bccefe-8d2e-85b5-e063-6394a90a58ca2025-08-13Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAmerican Health Packaging8b046ee6-28fc-4ab1-b543-414ad0103e5c2025-08-04Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENMethod Pharmaceuticals LLC1a9db542-d2b0-141a-e063-6394a90acc112025-07-23Warnings, Adverse reactionsExact identifier
application number: ANDA212378
ndc (product): 58657-732
rxcui: 197391
rxcui: 430902
rxcui: 197392
spl id: 3aa113f3-27d5-328b-e063-6394a90af9e5
spl set id: 1a9db542-d2b0-141a-e063-6394a90acc11
unii: H789N3FKE8
BACLOFENBACLOFENTrifluent Pharma, LLC890df151-f4eb-4244-97c4-f1f10912e7532025-07-21Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepacka748da19-d3eb-499e-986c-2043a1356f2b2025-07-15Warnings, Adverse reactionsExact identifier
application number: ANDA212378
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENA-S Medication Solutionseb690a49-b87b-433f-9afe-2966406fe00e2025-07-15Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENA-S Medication Solutionsaf0ade6c-9dd4-42d3-879e-4201fbe585ee2025-07-15Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLC39ad22ca-f034-f605-e063-6294a90a08e42025-07-11Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLC3981db3e-672c-1634-e063-6294a90a4cd12025-07-09Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack3ac0f0d2-86d8-46d0-88e5-c243734b08142025-06-26Warnings, 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.