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 4 of 10 · 195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lactation Flow Drops 2149LACTATION FLOW DROPSProfessional Complementary Health Formulas66a063c4-aa38-4c8e-b361-ee841165edeb2026-01-08WarningsExact identifier
unii: L11K75P92J
Nocturnal Enuresis Drops 2011NOCTURNAL ENURESIS DROPSProfessional Complementary Health Formulas9cd29086-c9eb-4db1-a219-2a8bae3663d82026-01-08WarningsExact identifier
unii: L11K75P92J
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: L11K75P92J
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: L11K75P92J
Myosotis Combination 9234MYOSOTIS COMBINATIONProfessional Complementary Health Formulas8cc292dc-b959-4d81-8277-03044992fccb2026-01-08WarningsExact identifier
unii: L11K75P92J
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: L11K75P92J
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: L11K75P92J
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: L11K75P92J
BaclofenBACLOFENPalmetto Pharmaceuticals Inc.2422746c-afec-ad30-e063-6394a90a04032025-12-31Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
BaclofenBACLOFENNorthwind Health Company, LLC06bcfb08-2ada-f803-e063-6394a90a826b2025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENAdvanced Rx of Tennessee, LLC459ec5f5-4f99-e917-e063-6294a90a23cd2025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENWilshire Pharmaceuticals, Inc.4585aafe-0af8-4786-a419-6a7e76671ca22025-12-16Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
FLEQSUVYBACLOFENAzurity Pharmaceuticals, Inc.9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa2025-12-16Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENPHOENIX RX LLC45c6d45d-95d5-21b8-e063-6294a90a79552025-12-12Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENUpsher-Smith Laboratories, LLCb2747a9d-5fca-4657-9e4b-4112607f30d82025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENAdvagen Pharma Limitedd63af5f0-c275-480b-89b5-6cf1ad55ab632025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENSOLA Pharmaceuticals, LLC7b308b35-8c08-458d-860e-c78d057e82602025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENANI Pharmaceuticals, Inc.c73ed3af-8e8a-4a18-90fc-a0f2dcc641d02025-12-04Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENProficient Rx LP0680301a-1649-46c4-b74e-ab03967945d02025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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