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 2 of 10 · 197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENAvPAKbc9040d9-1c54-9d62-e053-2a95a90a6ae32026-05-06Warnings, Adverse reactionsExact identifier
application number: ANDA211659
ndc (package): 50268-107-15
ndc (package): 50268-106-15
ndc (package): 50268-107-11
ndc (package): 50268-106-11
ndc (product): 50268-106
ndc (product): 50268-107
rxcui: 197391
rxcui: 197392
spl id: 5128fbd5-ce74-2c6a-e063-6294a90ad95f
spl set id: bc9040d9-1c54-9d62-e053-2a95a90a6ae3
unii: H789N3FKE8
BaclofenBACLOFENCoupler LLC5023c690-fd86-bb7d-e063-6394a90af6cd2026-04-23Warnings, Adverse reactionsExact identifier
application number: ANDA211659
ndc (package): 67046-1072-3
ndc (product): 67046-1072
rxcui: 197391
spl id: 5023daca-e46c-c225-e063-6394a90ab41b
spl set id: 5023c690-fd86-bb7d-e063-6394a90af6cd
unii: H789N3FKE8
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
BaclofenBACLOFENCardinal Health 107, LLC2278954a-7605-426a-ae85-1bf0a31174202026-04-22Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENGolden State Medical Supply, Inc.32336e92-89a4-7d7f-e063-6394a90ae9242026-04-21Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENCardinal Health 107, LLCa0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c2026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENMedcore LLC13eca70c-3cc8-4317-83cf-ade3327e48c02026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.ee59a379-17d5-487f-b72f-a53e74744a702026-03-27Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.91175128-8285-4d04-89a9-219781be92602026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 430902
unii: H789N3FKE8
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.16266972-843e-4ea5-be1f-fb1b1588a5dc2026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.0a1d09ac-94d5-45ef-92cc-bc261c2b2d752026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENA-S Medication Solutions4f84b27a-725a-48e6-a58a-85bbb395f4ae2026-03-23Warnings, Adverse reactionsExact identifier
application number: ANDA211659
ndc (package): 50090-7928-0
ndc (product): 50090-7928
rxcui: 197391
spl id: 1b52fad3-ad59-40d1-803e-0f617402c19c
spl set id: 4f84b27a-725a-48e6-a58a-85bbb395f4ae
unii: H789N3FKE8
BACLOFENBACLOFENPreferred Pharmaceuticals Inc.d20cc8b2-5236-4c87-b395-0acaaf7b62dd2026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENA-S Medication Solutions5f6a86f9-9658-4210-a47c-62907edfd4162026-03-19Warnings, Adverse reactionsExact identifier
application number: ANDA211659
ndc (package): 50090-6149-0
ndc (package): 50090-6149-3
ndc (package): 50090-6149-1
ndc (product): 50090-6149
rxcui: 197391
spl id: 3a481578-f289-4564-b630-9a8604a01d1f
spl set id: 5f6a86f9-9658-4210-a47c-62907edfd416
unii: H789N3FKE8
BACLOFENBACLOFENPreferred Pharmaceuticals Inc.9bd46eb6-53b2-4845-88b4-81c1ced08aaa2026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENPreferred Pharmaceuticals Inc.5e479876-adfb-4590-ac10-3924ff7988b02026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENPreferred Pharmaceuticals Inc.3fdfeef9-68b3-4f6c-a4de-28179758a9622026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENRedpharm Drug4ce1de84-72e1-57d3-e063-6294a90a220f2026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
OZOBAX DSBACLOFENRosemont Pharmaceuticals LLCd8ddcec5-debe-42b4-a803-e65917cc6a542026-03-13Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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