FDA.reportPublic FDA data

NDC 63629-8324-01 - TRAMADOL HYDROCHLORIDE

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
63629-8324
Requested NDC
63629-8324-01
Package NDCs from labels
63629-8324-1, 63629-8324-2, 63629-8324-3, 63629-8324-4, 63629-8324-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TRAMADOL HYDROCHLORIDE - Bryant Ranch PrepackBryant Ranch Prepack2026-04-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8324-1TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE301006
63629-8324-2TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE601006
63629-8324-3TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE901006
63629-8324-4TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE1201006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8324TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1005Current NDC, Legacy NDC, 4 package rows20240511_a77b0dba-8ac7-418a-b435-16a0e6c22804.zip

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 7 of 14 · 275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.004de5a4-80f8-4040-a6ea-be5e99352a362025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201384
ndc (product): 47335-861
rxcui: 833713
rxcui: 833709
rxcui: 833711
spl id: a994e116-d201-47f9-baaf-dd76a84eba7e
spl set id: 004de5a4-80f8-4040-a6ea-be5e99352a36
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAurobindo Pharma Limited6c2894df-eeeb-4b22-ab32-8ce1601bfdfa2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDERedPharm Drug Incf4c148f3-845a-61e3-e053-2a95a90a326e2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: 6DC9Q167V3
KINKANAMMONIA, CAMPHOR (NATURAL), MENTHOLKINKANDO CO., LTD .f2c0f3e1-792b-4798-bf6d-acd1bbefa2612025-10-21WarningsExact identifier
unii: 5138Q19F1X
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: 6DC9Q167V3
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.f558c59c-cbd4-4b17-9a3d-b014ad09bbb12025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.c30f6e9e-8014-40fc-9615-a6b8654137c12025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833709
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.e6e275c3-1e16-4a00-b7fd-608ae6cbd5152025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack2bf66203-8b45-475d-9a70-4d7c8bdfe6b32025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
UpSniff Smelling SaltsSMELLING SALTSShenzhen Nanjun Technology Co., Ltd3e7e4c2c-08bc-37b7-e063-6394a90a6b212025-09-10WarningsExact identifier
unii: 5138Q19F1X
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEA-S Medication Solutionsc28c98ac-7e07-46a5-8f34-57c008308fba2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833709
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAmerican Health Packagingf6f6069b-cc75-4b87-afa5-b83001b543e02025-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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