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 2 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENAvPAKbc9040d9-1c54-9d62-e053-2a95a90a6ae32026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENCoupler LLC5023c690-fd86-bb7d-e063-6394a90af6cd2026-04-23Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENCardinal Health 107, LLC2278954a-7605-426a-ae85-1bf0a31174202026-04-22Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENGolden State Medical Supply, Inc.32336e92-89a4-7d7f-e063-6394a90ae9242026-04-21Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENCardinal Health 107, LLCa0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c2026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENMedcore LLC13eca70c-3cc8-4317-83cf-ade3327e48c02026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.ee59a379-17d5-487f-b72f-a53e74744a702026-03-27Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.91175128-8285-4d04-89a9-219781be92602026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 430902
unii: H789N3FKE8
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.16266972-843e-4ea5-be1f-fb1b1588a5dc2026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.0a1d09ac-94d5-45ef-92cc-bc261c2b2d752026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENA-S Medication Solutions4f84b27a-725a-48e6-a58a-85bbb395f4ae2026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENPreferred Pharmaceuticals Inc.d20cc8b2-5236-4c87-b395-0acaaf7b62dd2026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENA-S Medication Solutions5f6a86f9-9658-4210-a47c-62907edfd4162026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENPreferred Pharmaceuticals Inc.5e479876-adfb-4590-ac10-3924ff7988b02026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENPreferred Pharmaceuticals Inc.3fdfeef9-68b3-4f6c-a4de-28179758a9622026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENRedpharm Drug4ce1de84-72e1-57d3-e063-6294a90a220f2026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
OZOBAX DSBACLOFENRosemont Pharmaceuticals LLCd8ddcec5-debe-42b4-a803-e65917cc6a542026-03-13Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENLifestar Pharma LLCf9dd1b55-2984-446a-8146-2ab0f5211e152026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENA-S Medication Solutions7ee42a29-21c2-47f8-a5b3-f3af115b665d2026-02-24Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENMajor Pharmaceuticals46f84504-ffc4-4be5-9598-c20a3f4210f42026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 430902
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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