FDA.reportPublic FDA data

NDC 70710-1609-01 - 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
70710-1609
Requested NDC
70710-1609-01
Package NDCs from labels
70710-1609-1, 70710-1609-01
Manufacturer
AvPAK
Effective date
2026-06-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - AvPAKAvPAK2026-06-29HUMAN PRESCRIPTION DRUG LABEL
Baclofen - American Health PackagingAmerican Health Packaging2025-08-04HUMAN PRESCRIPTION DRUG LABEL
BACLOFEN TABLETS USP Rx onlyZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited2024-08-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1609-1Baclofen100 in 1 BOTTLETABLET10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1609BACLOFEN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11Current NDC, Legacy NDC, 1 package rows20240815_cfc49176-8d01-4c39-9319-604dd087065c.zip

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 10 · 195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACLOFENBACLOFENAurobindo Pharma Limitedf4e8cbc5-b1f2-4331-a267-d5bd90bcde8a2025-11-24Warnings, Adverse reactionsExact identifier
rxcui: 430902
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack8a39dbc7-99d7-49e4-b5a1-cf70e7d753b22025-11-12Warnings, Adverse reactionsExact identifier
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
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: 2679605
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAmerican Health Packaging8b046ee6-28fc-4ab1-b543-414ad0103e5c2025-08-04Warnings, Adverse reactionsExact identifier
application number: ANDA211659
ndc (package): 60687-815-65
ndc (package): 60687-826-11
ndc (package): 60687-815-01
ndc (package): 60687-815-11
ndc (package): 60687-826-01
ndc (package): 60687-804-11
ndc (package): 60687-804-65
ndc (product): 60687-815
ndc (product): 60687-826
ndc (product): 60687-804
rxcui: 197391
rxcui: 430902
rxcui: 197392
spl id: 3b8a78f0-cf6e-1adb-e063-6294a90a55e6
spl set id: 8b046ee6-28fc-4ab1-b543-414ad0103e5c
unii: H789N3FKE8
BaclofenBACLOFENMethod Pharmaceuticals LLC1a9db542-d2b0-141a-e063-6394a90acc112025-07-23Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENTrifluent Pharma, LLC890df151-f4eb-4244-97c4-f1f10912e7532025-07-21Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltdc277f1d8-2ee0-4111-adb6-38998f77dede2025-07-18WarningsExact identifier
unii: L11K75P92J
BaclofenBACLOFENBryant Ranch Prepacka748da19-d3eb-499e-986c-2043a1356f2b2025-07-15Warnings, Adverse reactionsExact identifier
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

Reported adverse events (FAERS/openFDA)#

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