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 6 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCc85a9d82-1d61-aeec-e053-2995a90a03a42024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
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
rxcui: 197391
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
rxcui: 430902
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCf5edb656-4f7e-2386-e053-2995a90a70de2024-11-15Warnings, Adverse reactionsExact identifier
application number: ANDA212378
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENChartwell RX, LLC2a75db96-590a-43cf-aefb-3bbcb287dbf02024-10-10Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENNCS HealthCare of KY, LLC dba Vangard Labsea4ad5c5-207c-4a68-8e6e-4ff101777e5c2024-10-04Warnings, Adverse reactionsExact identifier
rxcui: 430902
unii: H789N3FKE8
BaclofenBACLOFENProficient Rx LPb981eb16-a195-41da-a186-3e91b63b2def2024-10-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
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
rxcui: 197391
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

Reported adverse events (FAERS/openFDA)#

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