FDA.reportPublic FDA data

NDC 68084-855-11 - 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
68084-855
Requested NDC
68084-855-11
Package NDCs from labels
68084-855-11, 68084-855-01
Manufacturer
American Health Packaging
Effective date
2022-11-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - American Health PackagingAmerican Health Packaging2022-11-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-855-01EA - Each68084-8555f7b92c7-051a-401e-a511-046fef8a63b612015-04-03
68084-855-11EA - Each68084-855e3b7f940-6fcf-43ef-af02-f727e06ae0f812015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [AMERICAN HEALTH PACKAGING]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 38 of 38 · 751 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H-Nail Fungus FormulaCALENDULA OFFICINALIS, SILICEA, THUJA OCCIDENTALISHealing Natural Oils LLC68f87ae5-fa3a-45cf-971c-c09e98106dd82017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCdd4b9972-0295-4555-a90b-bb087170cfbb2017-12-07Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
Homeoplex FECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEASupplement Clinic, LLC.a1872d34-7298-4016-b7b3-830ac11491262017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Homeoplex PASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), SCROPHULARIA NODOSA, TABEBUIA IMPETIGINOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMSupplement Clinic, LLC.3c0450c8-956e-4788-9e4d-55d30052ca0b2017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
PertussisACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, IPECACUANHA, STICTA PULMONARIA, TABACUM, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, SILICEA, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.b50b5a93-dbb5-4be9-91ac-7513f0ee34102017-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-HPBORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLINUM, SILICEABioActive Nutritional, Inc.1758624d-7ed8-49a6-ab24-2aab57703c912017-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
ParathyroplexPARATHYROID GLAND (BOVINE), BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, RHUS TOX, SILICEABioActive Nutritional, Inc.37649bb9-cbd7-4971-b410-18ea307c46f62017-04-18WarningsExact identifier
unii: ETJ7Z6XBU4
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corp9883c502-9782-451e-9eec-c54d7b054f312017-01-31WarningsExact identifier
unii: ETJ7Z6XBU4
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: ETJ7Z6XBU4
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
TeethingARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEABioActive Nutritional, Inc.f39c9feb-f567-43a2-a026-2a581aeeed9d2016-07-27WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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