NDC 63629-8014-01 - Metaxalone

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
63629-8014
Requested NDC
63629-8014-01
Package NDCs from labels
63629-8014-1, 63629-8014-2, 63629-8014-3, 63629-8014-4, 63629-8014-5, 63629-8014-6, 63629-8014-7, 63629-8014-8, 63629-8014-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metaxalone - Bryant Ranch PrepackBryant Ranch Prepack2024-07-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8014-1Metaxalone30 in 1 BOTTLETABLET3010
63629-8014-2Metaxalone90 in 1 BOTTLETABLET9010
63629-8014-3Metaxalone100 in 1 BOTTLETABLET10010
63629-8014-4Metaxalone60 in 1 BOTTLETABLET6010
63629-8014-5Metaxalone10 in 1 BOTTLETABLET1010
63629-8014-6Metaxalone20 in 1 BOTTLETABLET2010
63629-8014-7Metaxalone120 in 1 BOTTLETABLET12010
63629-8014-8Metaxalone15 in 1 BOTTLETABLET1510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8014METAXALONE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 8 package rows20240726_07ccff59-e335-40be-9e40-fd2d08197617.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8014-1EA - Each63629-8014aed0c3cb-758d-43d7-a34a-4e6362e7643812021-01-08
63629-8014-2EA - Each63629-80147b3f8cdb-db56-4602-859d-bbd8373bdadd12021-01-08
63629-8014-3EA - Each63629-8014d6f0c5d8-170d-4512-8651-465f0728280d12020-06-05
63629-8014-4EA - Each63629-8014e64b386b-f672-4958-aae3-a2e3045baf6212020-02-13
63629-8014-5EA - Each63629-801423a21dc0-2edc-44b8-8571-f7403be5450012021-01-08
63629-8014-7EA - Each63629-8014f5aecf78-2f46-4432-b308-4efa88f361df12025-09-12

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 4 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetaxaloneMETAXALONEProficient Rx LPee86f52c-fbf4-4882-bb7d-50220736fbb32022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEDoc Rx4a558a2f-f9be-40d1-8d02-dd0c8c501ef62022-03-24Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEDoc Rx87518046-c959-d5f3-e053-2a95a90a5f7e2021-09-28Warnings, Adverse reactionsExact identifier
application number: ANDA203695
rxcui: 351254
unii: 1NMA9J598Y

Reported adverse events (FAERS/openFDA)#

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