FDA.reportPublic FDA data

NDC 63561-0127-02 - Carisoprodol Tablets, USP, 350 mg

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
63561-0127
Requested NDC
63561-0127-02
Package NDCs from labels
63561-0127-1, 63561-0127-2, 63561-0127-02
Manufacturer
Bryant Ranch Prepack
Effective date
2025-12-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Carisoprodol Tablets, USP, 350 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-12-03HUMAN PRESCRIPTION DRUG LABEL
Carisoprodol Tablets, USP, 350 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-12-01HUMAN PRESCRIPTION DRUG LABEL
Carisoprodol Tablets, USP, 350 mg - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2025-10-23HUMAN PRESCRIPTION DRUG LABEL
Carisoprodol Tablets, USP, 350 mg - Granulation Technology, Inc.Granulation Technology, Inc.2025-06-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0127-1Carisoprodol Tablets, USP, 350 mg100 in 1 BOTTLE, PLASTICTABLET1002
63561-0127-2Carisoprodol Tablets, USP, 350 mg1000 in 1 BOTTLE, PLASTICTABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63561-0127CARISOPRODOL TABLETS, USP, 350 MG (CARISOPRODOL) TABLET [GRANULATION TECHNOLOGY, INC.]1Current NDC, 2 package rows20240310_2abd11e4-8ce4-4aeb-87c4-3af94c197714.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63561-0127-1EA - Each63561-0127dcf51cf4-0a6f-4329-acbf-26fffc99137112025-07-08
63561-0127-2EA - Each63561-0127995e6fc5-da9d-4a6a-9139-d0ebad6288ab12025-07-08

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 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLREMEDYREPACK INC.b83f7fd1-11e3-4e94-ae53-4637e892b3722026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLNorthwind Health Company, LLC26e466be-8066-e562-e063-6394a90a9f812026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLSt. Mary's Medical Park Pharmacy94f74800-1f0d-7814-e053-2a95a90a4f632026-06-17Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack269644bf-d32c-48a3-b3eb-1221150ebd222026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
carisoprodolCARISOPRODOLREMEDYREPACK INC.eebb9409-e333-4b9f-8059-6588c35ab5782026-06-05Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack59f6f0e3-fdbd-4788-9944-37edde4b9a3c2026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLBryant Ranch Prepacka3f1343f-1337-4b99-b1ae-4189324ec2e92026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack93f909ea-2d2e-4a10-be50-7f33f3e904d42026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLWestminster Pharmaceuticals, LLCbfb31551-8c57-4360-be3a-f6fbe84a891e2026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLDirectrxd5cc9f99-59ae-55db-e053-2995a90affb72026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLScieGen Pharmaceuticals, Inc.069ea892-21a6-4703-8dd3-bf19c44064792026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLA-S Medication Solutions6c15f559-c045-4271-86ef-e001aad39c332026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLA-S Medication Solutions88f9b969-4225-49d6-9e4c-8c397ba7b50c2026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLDirect_Rx8e9bb49a-8cc3-4390-e053-2a95a90a4e0e2026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLChartwell RX, LLCa44a3dfc-a427-4584-a086-4bc0c538b1252025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLBryant Ranch Prepack35a8e0a4-93a3-44e3-903f-4661ee1cffe82025-12-03Warnings, Adverse reactionsExact identifier
application number: ANDA211789
ndc (package): 71335-3018-1
ndc (product): 71335-3018
rxcui: 197446
spl id: 4799ce2f-75ce-4e7b-9b9c-1322a1f4b897
spl set id: 35a8e0a4-93a3-44e3-903f-4661ee1cffe8
unii: 21925K482H
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLBryant Ranch Prepack409b04af-b9fd-4ba5-afa0-3e43466f8d2d2025-12-01Warnings, Adverse reactionsExact identifier
application number: ANDA211789
ndc (package): 72162-2525-0
ndc (package): 72162-2525-1
ndc (package): 72162-2525-2
ndc (product): 72162-2525
rxcui: 197446
spl id: ad5c9fff-69c8-40a5-97a0-6a51d35fb9d5
spl set id: 409b04af-b9fd-4ba5-afa0-3e43466f8d2d
unii: 21925K482H
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLPD-Rx Pharmaceuticals, Inc.1f08f4af-37c2-49b5-a4e3-284414f866fa2025-10-23Warnings, Adverse reactionsExact identifier
application number: ANDA211789
ndc (package): 72789-477-95
ndc (package): 72789-477-01
ndc (package): 72789-477-98
ndc (package): 72789-477-30
ndc (package): 72789-477-90
ndc (product): 72789-477
rxcui: 197446
spl id: 41d80caa-d146-cdc1-e063-6294a90a8dc3
spl set id: 1f08f4af-37c2-49b5-a4e3-284414f866fa
unii: 21925K482H
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
SomaCARISOPRODOLViatris Specialty LLC6297cf20-830a-11dc-94c8-0002a5d5c51b2025-08-29Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H

Reported adverse events (FAERS/openFDA)#

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