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 2 of 14 · 279 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.16053b28-c759-4914-93e6-2de0afe724452026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833709
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy42de8c3a-0441-5d46-e063-6294a90a20792026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.6bb5be12-59ff-40f4-9841-9c7ab93be2ea2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833711
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacycb05d615-918d-8104-e053-2995a90aa96b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC552e5b32-accf-29dd-e063-6294a90a4fcf2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDENorthwind Health Company, LLC552955e6-2bb3-8755-e063-6394a90ab21c2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDECoupler LLC54d74939-301b-e603-e063-6394a90a3b032026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack515baa9a-b226-4bbe-be87-f9befdf1c9e12026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEREMEDYREPACK INC.5199132e-745e-46a0-8068-e06d1bca5c612026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.855905c7-1481-4b2d-a318-3254ad8ed73c2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPaefc85bc-0820-4aee-8d94-313c5f1658f52026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833709
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEMajor Pharmaceuticals6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e22026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackccf465b5-8ef8-4445-a0d4-23b5cf13188c2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack66359f41-9999-4cb8-b632-1fe2ec1e60b22026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201384
rxcui: 833711
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack43fe10b2-17a4-4dc2-9a48-2378547b61fd2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201384
rxcui: 833709
unii: 9N7R477WCK
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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