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 3 of 10 · 195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
BaclofenBACLOFENBryant Ranch Prepack80b0a41e-2cad-4e14-9605-0cd35f9991e92026-02-05Warnings, Adverse reactionsExact identifier
rxcui: 430902
unii: H789N3FKE8
BACLOFENBACLOFENBryant Ranch Prepack7df6e691-f1d5-441c-b5bb-a3867983e09f2026-02-05Warnings, Adverse reactionsExact identifier
rxcui: 430902
unii: H789N3FKE8
BaclofenBACLOFENPreferred Pharmaceuticals, Inc.58416ceb-994f-4571-afbd-c2171823f5282026-01-26Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENAdvagen Pharma Limited04dac0f6-cc6c-4959-9bca-a6e4a99690f32026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 2679605
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENPreferred Pharmaceuticals Inc.69d0027a-cb46-4754-9225-071ec1ce4b372026-01-21Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENA-S Medication Solutions975fda6d-d929-482b-8be7-60849026dbdd2026-01-20Warnings, Adverse reactionsExact identifier
application number: ANDA211659
rxcui: 197392
unii: H789N3FKE8
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
BaclofenBACLOFENBryant Ranch Prepack808113db-c5c2-404c-ab5f-62b991641cfe2026-01-12Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENMajor Pharmaceuticalsae732bdc-5178-4565-8219-d1787a5211a62026-01-09Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: L11K75P92J
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: L11K75P92J
Rib Cage Pain Drops 2056RIB CAGE PAIN DROPSProfessional Complementary Health Formulasf8051769-9714-4444-b736-04b95af64a9b2026-01-08WarningsExact identifier
unii: L11K75P92J
Seventh Chakra (Crown) 7307SEVENTH CHAKRA (CROWN)Professional Complementary Health Formulas06a2e818-ce9a-4930-adef-5b9990f1b8a32026-01-08WarningsExact identifier
unii: L11K75P92J
Memory Drops 2043MEMORY DROPSProfessional Complementary Health Formulasa9b8897b-e5a1-4db3-94dd-8012aded6ed72026-01-08WarningsExact identifier
unii: L11K75P92J
Calcarea Phosphorica 8002CALCAREA PHOSPHORICAProfessional Complementary Health Formulas555dd940-ed07-4160-bae3-1b4d320dec662026-01-08WarningsExact identifier
unii: L11K75P92J
Calcarea Combination 9214CALCAREA COMBINATIONProfessional Complementary Health Formulas54b605d6-1e58-41b1-865b-1280ed75d4942026-01-08WarningsExact identifier
unii: L11K75P92J
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: L11K75P92J
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: L11K75P92J

Reported adverse events (FAERS/openFDA)#

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