FDA.reportPublic FDA data

NDC 50090-4682-01 - 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
50090-4682
Requested NDC
50090-4682-01
Package NDCs from labels
50090-4682-0, 50090-4682-1, 50090-4682-2, 50090-4682-3, 50090-4682-01
Manufacturer
A-S Medication Solutions
Effective date
2026-01-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - A-S Medication SolutionsA-S Medication Solutions2026-01-20HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-4682-02023-02-07BACLOFEN TABLETS USP Rx only
50090-4682-12023-02-07BACLOFEN TABLETS USP Rx only
50090-4682-22023-02-07BACLOFEN TABLETS USP Rx only
50090-4682-32023-02-07BACLOFEN TABLETS USP Rx only
50090-4682-02023-01-30BACLOFEN TABLETS USP Rx only
50090-4682-12023-01-30BACLOFEN TABLETS USP Rx only
50090-4682-22023-01-30BACLOFEN TABLETS USP Rx only
50090-4682-32023-01-30BACLOFEN TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4682-0Baclofen20 in 1 BOTTLETABLET2012
50090-4682-1Baclofen60 in 1 BOTTLETABLET6012
50090-4682-2Baclofen30 in 1 BOTTLETABLET3012
50090-4682-3Baclofen90 in 1 BOTTLETABLET9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4682BACLOFEN TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 4 package rows20240430_975fda6d-d929-482b-8be7-60849026dbdd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4682-1EA - Each50090-4682a8fc15fc-6d4b-4788-ba03-566e76bdfed012024-02-14
50090-4682-2EA - Each50090-46823eb7237c-6305-44d3-b5e3-74c0e2f28cf312024-02-14
50090-4682-3EA - Each50090-46828d51c202-45e2-4b14-8427-b07835e7953a12024-02-14

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
ndc (package): 50090-4682-1
ndc (package): 50090-4682-0
ndc (package): 50090-4682-3
ndc (package): 50090-4682-2
ndc (product): 50090-4682
ndc11 (package): 50090468201
rxcui: 197392
spl id: 0825b008-5a6d-4ad7-8cdb-73ebb6692302
spl set id: 975fda6d-d929-482b-8be7-60849026dbdd
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.