FDA.reportPublic FDA data

NDC 63629-1228-01 - 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
63629-1228
Requested NDC
63629-1228-01
Package NDCs from labels
63629-1228-1, 63629-1228-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-04-02
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 Prepack2024-04-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1228-1Baclofen100 in 1 BOTTLETABLET100104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1228BACLOFEN TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240514_d24135b3-e247-412f-a10b-ceecbdee3aef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1228-1EA - Each63629-122805fd5535-f8dd-4513-a0f4-ef0f5dc0518c12021-03-02

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
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: 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
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
unii: H789N3FKE8
BaclofenBACLOFENCardinal Health 107, LLC3c87e116-871d-46b8-897b-fc27a17b988d2026-07-24Warnings, Adverse reactionsExact identifier
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
unii: H789N3FKE8
BACLOFENBACLOFENNuCare Pharmaceuticals, Inc.2517f71f-f452-1f56-e063-6394a90a6ef12026-06-25Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENRedpharm Drug53df4b4b-842e-9e3a-e063-6394a90a8a3d2026-06-10Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENREMEDYREPACK INC.d689d32c-12a7-4ae4-afc3-8a353be671482026-06-01Warnings, Adverse reactionsExact identifier
application number: ANDA212378
unii: H789N3FKE8
BaclofenBACLOFENEywa Pharma Inc7ec59f6b-7c4f-432d-ba27-442861806b6c2026-05-16Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENREMEDYREPACK INC.e017a001-8cb1-4dd8-960e-c6d74005f57f2026-05-12Warnings, Adverse reactionsExact identifier
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.