FDA.reportPublic FDA data

NDC 71335-2669-02 - 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
71335-2669
Requested NDC
71335-2669-02
Package NDCs from labels
71335-2669-1, 71335-2669-2, 71335-2669-3, 71335-2669-02
Manufacturer
Bryant Ranch Prepack
Effective date
2025-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - Bryant Ranch PrepackBryant Ranch Prepack2025-06-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2669-1Baclofen100 in 1 BOTTLETABLET100100
71335-2669-2Baclofen1000 in 1 BOTTLETABLET1000100
71335-2669-3Baclofen120 in 1 BOTTLETABLET120100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2669-1EA - Each71335-266916fd579e-5582-4ccd-879a-8c3330d6e90412025-08-11
71335-2669-2EA - Each71335-26696c47e8a0-d3c8-4a03-8459-88a311de138012025-08-11
71335-2669-3EA - Each71335-2669fd1fb04a-0f59-43b4-8ad3-18712cd842c612025-08-11

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 9 · 170 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
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
application number: ANDA212378
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
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
application number: ANDA212378
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.