FDA.reportPublic FDA data

NDC 60687-826-11 - 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
60687-826
Requested NDC
60687-826-11
Package NDCs from labels
60687-826-11, 60687-826-01
Manufacturer
American Health Packaging
Effective date
2025-08-04
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 Packaging2025-08-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-826-01Baclofen100 in 1 CARTONTABLET1004
60687-826-11Baclofen1 in 1 BLISTER PACKTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-826BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20240526_8b046ee6-28fc-4ab1-b543-414ad0103e5c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-826-01EA - Each60687-826d20ed42b-d022-4736-8966-e512e30e2e1412024-06-10
60687-826-11EA - Each60687-82644f179ff-7286-4c0d-b4a1-48f1deb7590f12024-06-10

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 1 of 10 · 196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACLOFENBACLOFENREMEDYREPACK INC.ab3760cd-a84b-49ba-88e3-b9ea73c55f822026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENAtlantic Biologicals Corp.50b3e7be-832b-313d-e063-6394a90a5ab42026-09-04Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENREMEDYREPACK INC.4e2cd27d-91c7-4f15-96cc-3971769dbeaa2026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENREMEDYREPACK INC.c2e1d183-7061-459b-a631-206b06d127532026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENPar Health USA, LLCc17527be-661d-42f5-b6f6-56a681ba78702026-08-24Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepackaeb56b0e-7126-4417-b726-e8a54f73de3f2026-08-24Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENREMEDYREPACK INC.ac9b720f-b755-49f1-9850-efb26feadaeb2026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENREMEDYREPACK INC.355266e4-68f7-47d7-9f4e-1a0fc912786d2026-08-10Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENREMEDYREPACK INC.76896b07-2835-4467-b386-87ec66ddd88e2026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENCardinal Health 107, LLC3c87e116-871d-46b8-897b-fc27a17b988d2026-07-24Warnings, Adverse reactionsExact identifier
application number: ANDA211659
rxcui: 430902
unii: H789N3FKE8
BaclofenBACLOFENPreferred Pharmaceuticals Inc.3047613d-006b-4011-b5fe-098588f474aa2026-07-22Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENREMEDYREPACK INC.6274e70a-fb57-461b-b1bc-39d4ff916b2a2026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENREMEDYREPACK INC.ebbfec9e-621c-4d04-8a1c-81d2eb9e9c742026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENAvPAKc21095a9-17b1-555a-e053-2a95a90a51fd2026-06-29Warnings, Adverse reactionsExact identifier
application number: ANDA211659
rxcui: 430902
unii: H789N3FKE8
BACLOFENBACLOFENNuCare Pharmaceuticals, Inc.2517f71f-f452-1f56-e063-6394a90a6ef12026-06-25Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENRedpharm Drug53df4b4b-842e-9e3a-e063-6394a90a8a3d2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENREMEDYREPACK INC.d689d32c-12a7-4ae4-afc3-8a353be671482026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENEywa Pharma Inc7ec59f6b-7c4f-432d-ba27-442861806b6c2026-05-16Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 430902
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENREMEDYREPACK INC.e017a001-8cb1-4dd8-960e-c6d74005f57f2026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 430902
unii: H789N3FKE8
GablofenBACLOFEN INJECTIONPiramal Critical Care Inc00d3e846-dd92-448d-9ab8-6a07be823cc12026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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