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 12 of 12 · 238 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LYVISPAHBACLOFENAmneal Pharmaceuticals LLCf8992a56-9010-4c4b-84d5-ddcc3e2c33172023-04-23Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENMAlA Pharmaceuticals, Inc.e05080ef-53d9-4060-aaa4-86a6935467de2023-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENMAlA Pharmaceuticals, Inc.dfa6148c-693c-45f1-89be-0e77d39f313e2023-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Lioresal (baclofen)BACLOFENAmneal Pharmaceuticals LLC6f3bdcc0-ffc8-4911-8c35-958c8103a2c52022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCedef7819-875f-4855-8f1f-32407f82e9dc2022-09-08Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENProficient Rx LPb65d3089-0412-487f-a1b4-66f0bc6f398e2022-03-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENSagent Pharmaceuticalsea32c39c-0ee3-4b5e-8da7-4c31db334bd82021-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENSagent Pharmaceuticals077aaf3b-1ca3-4599-a51a-6bbe39810ca82021-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENLannett Company, Inc.f84f3f4c-17e6-43f1-9600-63b0b175837b2021-02-24Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLC9edc00c6-c281-4e81-b176-44b7536f71f22020-08-13Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCd9e5a8b9-1524-41b4-942f-f95015dd17f92020-08-05Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENProficient Rx LP924a01fb-0ed0-4f73-9304-d6c5b9961d662020-05-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENTeva Pharmaceuticals USA, Inc.5648c772-50cb-4961-996e-e68a8eb699ea2019-12-31Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCdd4b9972-0295-4555-a90b-bb087170cfbb2017-12-07Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
5ebd1b75-510d-4dce-b880-a941d35bba5b31804ce6-5028-4f63-b737-ddb4275b95992011-01-01Warnings, Adverse reactionsExact identifier
spl id: 5ebd1b75-510d-4dce-b880-a941d35bba5b
spl set id: 31804ce6-5028-4f63-b737-ddb4275b9599
af7d40cc-756e-48ca-9eb3-f2fc8668541a455170de-dd54-4f56-9eb1-ffe5cfbdc0e22010-06-29Warnings, Adverse reactionsExact identifier
spl id: af7d40cc-756e-48ca-9eb3-f2fc8668541a
spl set id: 455170de-dd54-4f56-9eb1-ffe5cfbdc0e2
14878615-b39c-477e-b33d-dd9753c7a3cfd88886cc-62c0-44dd-8a3f-cac601832d8e2009-12-01Warnings, Adverse reactionsExact identifier
spl id: 14878615-b39c-477e-b33d-dd9753c7a3cf
spl set id: d88886cc-62c0-44dd-8a3f-cac601832d8e
50286EF2-499A-CADE-6559-8AD1B7D3280BAADEE2AB-113B-4CD4-8184-575C3F4969902007-01-08Warnings, Adverse reactionsExact identifier
spl id: 50286EF2-499A-CADE-6559-8AD1B7D3280B
spl set id: AADEE2AB-113B-4CD4-8184-575C3F496990

Reported adverse events (FAERS/openFDA)#

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