FDA.reportPublic FDA data

tramadol hydrochloride

Product NDC
53002-4322
11-digit product format
530024322
Labeler code
53002
Product ID
53002-4322_542bfe25-db5f-4d96-9a79-ab70acd5072f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075964
Marketing category
ANDA
Marketing start
2002-06-22
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
377068df-225f-7318-a910-a1987cdfa361Product name320170608
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-4322-12025-01-30C16284748780-12cef2736-78e1-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
53002-4322-22025-01-30C16284748780-12cef2736-78e1-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
53002-4322-32025-01-30C16284748780-12cef2736-78e1-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4322-1tramadol hydrochloride10 in 1 BOTTLETABLET101
53002-4322-2tramadol hydrochloride20 in 1 BOTTLETABLET201
53002-4322-3tramadol hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4322TRAMADOL HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20220331_dd5387d7-17c3-4949-978a-3ca5578364c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNdd5387d7-17c3-4949-978a-3ca5578364c11
835603tramadol hydrochloride 50 MG Oral TabletSCDdd5387d7-17c3-4949-978a-3ca5578364c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4322-15300243220110 TABLET in 1 BOTTLE (53002-4322-1) 10 tablet2021-01-010000-00-00NoNoCurrent
53002-4322-25300243220220 TABLET in 1 BOTTLE (53002-4322-2) 20 tablet2021-01-010000-00-00NoNoCurrent
53002-4322-35300243220330 TABLET in 1 BOTTLE (53002-4322-3) 30 tablet2021-01-010000-00-00NoNoCurrent