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 5 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACLOFENBACLOFENAdvagen Pharma Ltd2a43830f-a28b-ca15-e063-6294a90a6b1a2025-06-12Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENHAWAII REPACK, INC.bc48a775-1feb-44c4-9453-e1ccf3d929bd2025-06-11Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAdvagen Pharma Ltd.,75ab298b-b2a7-458f-accc-5bfc89b89a162025-06-11Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENAurobindo Pharma Limited4679a275-9307-4b0f-a2eb-2d83227ea84d2025-06-11Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENSagent Pharmaceuticalsd4bfba33-9f4d-4c43-ae6c-bcf67ef8fe512025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENProficient Rx LP0243dd97-1d40-48f7-8853-76e046c605f22025-04-01Warnings, Adverse reactionsExact identifier
rxcui: 430902
unii: H789N3FKE8
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
BaclofenBACLOFENBryant Ranch Prepack8cb96e7b-9c40-46a9-b964-7a573b7a03422025-02-21Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENXLCare Pharmaceuticals Inc.2b4908fb-47b5-4675-be9e-ca1ad48a72522025-02-05Warnings, Adverse reactionsExact identifier
application number: ANDA212378
rxcui: 197391
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENNuCare Pharmaceuticals,Inc.fd00fa8f-2797-c3f0-e053-6294a90a975f2025-02-05Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENAdvanced Rx of Tennessee, LLC2cf71f5f-6d46-7506-e063-6294a90a186f2025-01-30Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENDirect_Rx020632f4-5e8a-f4a0-e063-6294a90a63012025-01-28Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack4b215bc5-f7f9-4b39-b8ee-42b233ee4aa22025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack9bbcbf20-57ed-447b-9744-a5f10b9a057a2025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 430902
unii: H789N3FKE8
BACLOFENBACLOFENAsclemed USA, Inc.687f48da-bc41-4700-9513-77a32fc86c932025-01-15Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENNexus Pharmaceuticals LLC68c9ade0-d783-43e9-8a3f-a16ec1501ec12025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx of Tennessee, LLCb33c534d-4fa3-0a2f-e053-2995a90ab52f2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx of Tennessee, LLCb33c4164-e607-2e27-e053-2a95a90ad7db2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCb4f2f888-979a-6f54-e053-2a95a90a95a32024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCc85a1884-f46f-5cd4-e053-2a95a90a3e272024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA212378
rxcui: 197391
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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