FDA.reportPublic FDA data

NDC 0591-5730 - 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
0591-5730
Package NDCs from labels
0591-5730-01, 0591-5730-05
Manufacturer
Med Health Pharma, LLC
Effective date
2011-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - Med Health Pharma, LLCMed Health Pharma, LLC2011-01-01HUMAN PRESCRIPTION DRUG LABEL
BACLOFEN - STAT RX USA LLCSTAT RX USA LLC2010-06-29HUMAN PRESCRIPTION DRUG LABEL
Baclofen Tablets USP 10mg & 20mgRebel Distributors Corp.2009-12-01HUMAN PRESCRIPTION DRUG LABEL
Baclofen Tablets USP Revised: January 2004 Rx onlyWatson Laboratories, Inc.2007-01-08HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5730-01Bacolfen100 in 1 BOTTLETABLET1003
0591-5730-05Bacolfen500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5730BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]32 package rows20070126_AADEE2AB-113B-4CD4-8184-575C3F496990.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BaclofenACTIVE INGREDIENTH789N3FKE8BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
baclofenACTIVE MOIETYH789N3FKE8BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
Corn starchINACTIVE INGREDIENTBACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
Magnesium stearateINACTIVE INGREDIENT70097M6I30BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
Microcrystalline celluloseINACTIVE INGREDIENTBACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
PovidoneINACTIVE INGREDIENTBACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
BaclofenACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [MED HEALTH PHARMA, LLC]2
BaclofenACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [MED HEALTH PHARMA, LLC]2
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [STAT RX USA LLC]1
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [STAT RX USA LLC]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EBACLOFEN TABLET [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EBACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1

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 11 of 12 · 238 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
unii: FZ989GH94E
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
unii: FZ989GH94E
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E
BaclofenBACLOFENA-S Medication Solutionse163e7dc-45a5-43c2-b13d-a4453f2c360c2023-12-05Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENA-S Medication Solutions081d478a-2f3f-456e-bcca-00487589da6f2023-12-05Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
Baclofen (Intrathecal)BACLOFENMAIA Pharmaceuticals, Inc.11ba5575-a856-414a-89f8-17f3a01de55b2023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack58816b46-28a5-48e2-b89d-98df659393862023-10-20Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack9110b1cb-8604-4824-9337-84b08d41dd3c2023-10-20Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepackf9cf294a-85d1-4321-af68-4279b20c4b712023-10-19Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepackfded79a4-c354-448d-96dd-6dc69c46a0132023-10-19Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack2cd15814-5f70-4c65-9f43-367495486ecd2023-10-18Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENTRUPHARMA, LLCf8ec79c6-da65-4fb6-b6bd-45df0d2a52c72023-10-18Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack7ed13ef7-329e-40cb-b9b1-31a4bf32ac982023-08-29Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENBryant Ranch Prepack96f9caa3-0d36-4d99-8c6f-0da5b0d035272023-08-11Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENSlayback Pharma LLC9fad5ffc-afae-4c92-a672-ee636df45bc52023-06-16Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENUnichem Pharmaceuticals (USA), Inc.b9199878-3fb4-46dc-adbb-b3d9dc3852d42023-06-08Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENNCS HealthCare of KY, LLC dba Vangard Labs2927228a-7a3e-4e1d-ab5f-4407b00f68992023-05-31Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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