FDA.reportPublic FDA data

NDC 70710-1285-01 - 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
70710-1285
Requested NDC
70710-1285-01
Package NDCs from labels
70710-1285-1, 70710-1285-5, 70710-1285-0, 70710-1285-01
Manufacturer
AvPAK
Effective date
2026-05-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - AvPAKAvPAK2026-05-06HUMAN PRESCRIPTION DRUG LABEL
Baclofen - Coupler LLC | Zydus Lifesciences Global FZECoupler LLC | Zydus Lifesciences Global FZE2026-04-23HUMAN PRESCRIPTION DRUG LABEL
Baclofen - A-S Medication SolutionsA-S Medication Solutions2026-03-23HUMAN PRESCRIPTION DRUG LABEL
Baclofen - A-S Medication SolutionsA-S Medication Solutions2026-03-19HUMAN 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
BACLOFEN TABLETS USP Rx onlyPreferred Pharmaceuticals, Inc.2021-03-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1285-0Baclofen1000 in 1 BOTTLETABLET100011
70710-1285-1Baclofen100 in 1 BOTTLETABLET10011
70710-1285-5Baclofen500 in 1 BOTTLETABLET50011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1285BACLOFEN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11Current NDC, Legacy NDC, 3 package rows20240815_cfc49176-8d01-4c39-9319-604dd087065c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1285-0EA - Each70710-1285ebbd49ca-88f5-47e9-ba1f-f05f135bf60312019-01-24
70710-1285-1EA - Each70710-1285ab5ac565-8fc8-4944-8ff5-05118a3db6f512019-01-24
70710-1285-5EA - Each70710-12852b7c3e8d-ac8e-494f-8968-ea8be752f8a812019-01-24

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 10 of 10 · 196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
9626d986-a006-45de-8276-940971c68165ad74b15e-a4b6-483e-8bbc-63b90e1d41c22022-03-25Warnings, Adverse reactionsExact identifier
spl set id: ad74b15e-a4b6-483e-8bbc-63b90e1d41c2
BaclofenBACLOFENProficient Rx LPb65d3089-0412-487f-a1b4-66f0bc6f398e2022-03-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: L11K75P92J
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: 430902
rxcui: 197392
unii: H789N3FKE8
MEDULLOSSEINUM PLEXARNICA MONTANA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MEDULLOSSEINUM, PULSATILLA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALESeroyal USA22b7eafe-ef76-0677-e054-00144ff88e882020-10-09WarningsExact identifier
unii: L11K75P92J
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

Reported adverse events (FAERS/openFDA)#

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