FDA.reportPublic FDA data

NDC 58657-930-10 - 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
58657-930
Requested NDC
58657-930-10
Package NDCs from labels
58657-930-10, 58657-930-05, 58657-930-01
Manufacturer
Method Pharmaceuticals LLC
Effective date
2025-07-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - Method Pharmaceuticals LLCMethod Pharmaceuticals LLC2025-07-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-930-01Baclofen10 in 1 CARTONTABLET102
58657-930-05Baclofen5 in 1 CARTONTABLET52
58657-930-10Baclofen10 in 1 BLISTER PACKTABLET102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-930-01EA - Each58657-9304985a946-9e76-44b2-b50c-34df4dd89ad012025-09-12
58657-930-05EA - Each58657-93004d4a779-6a5a-4d86-8fef-5ea89974731e12025-09-12
58657-930-10EA - Each58657-930a66e2ba8-6129-49c7-b3d7-d17c3e3483d112025-11-13

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 (package): 58657-732-10
ndc (package): 58657-731-10
ndc (package): 58657-930-10
ndc (package): 58657-730-10
ndc (package): 58657-930-01
ndc (package): 58657-931-05
ndc (package): 58657-932-01
ndc (package): 58657-930-05
ndc (package): 58657-931-10
ndc (package): 58657-730-01
ndc (package): 58657-731-50
ndc (package): 58657-732-01
ndc (package): 58657-931-01
ndc (package): 58657-731-01
ndc (package): 58657-732-50
ndc (package): 58657-932-05
ndc (package): 58657-932-10
ndc (product): 58657-931
ndc (product): 58657-932
ndc (product): 58657-732
ndc (product): 58657-930
ndc (product): 58657-731
ndc (product): 58657-730
ndc11 (package): 58657093010
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.