FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
61919-229
11-digit product format
619190229
Labeler code
61919
Product ID
61919-229_e9e977cd-b92e-319d-e053-2995a90acb72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075964
Marketing category
ANDA
Marketing start
2019-08-20
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
61919-229-122025-01-30C16284748780-12cef2736-73d5-d83d-e063-dadaa90ab31fTRAMADOL HYDROCHLORIDE
61919-229-202025-01-30C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-302025-01-30C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-402025-01-30C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-712025-01-30C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-822025-01-30C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-842025-01-30C16284748780-12cef2736-73d5-d83d-e063-dadaa90ab31fTRAMADOL HYDROCHLORIDE
61919-229-902025-01-30C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-202022-09-28C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-712022-09-28C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-822022-09-28C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-902022-09-28C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-202020-01-31C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-712020-01-31C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-822020-01-31C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-229-902020-01-31C16284748780-19d75b9d1-1137-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-229-12TRAMADOL HYDROCHLORIDE12 in 1 BOTTLETABLET129
61919-229-84TRAMADOL HYDROCHLORIDE240 in 1 BOTTLETABLET2409
61919-229-20TRAMADOL HYDROCHLORIDE20 in 1 BOTTLETABLET207
61919-229-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET307
61919-229-40TRAMADOL HYDROCHLORIDE40 in 1 BOTTLETABLET407
61919-229-50TRAMADOL HYDROCHLORIDE50 in 1 BOTTLETABLET507
61919-229-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET607
61919-229-71TRAMADOL HYDROCHLORIDE100 in 1 BOTTLETABLET1007
61919-229-72TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET1207
61919-229-82TRAMADOL HYDROCHLORIDE180 in 1 BOTTLETABLET1807
61919-229-90TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-229TRAMADOL HYDROCHLORIDE TABLET [DIRECT_RX]9Legacy NDC, 2 package rows20230418_908cfd1e-d668-59c0-e053-2a95a90a92c2.zip
61919-229TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]7Legacy NDC, 9 package rows20221004_f4ae0017-5050-4b92-9944-340385152b95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN908cfd1e-d668-59c0-e053-2a95a90a92c29
835603tramadol hydrochloride 50 MG Oral TabletSCD908cfd1e-d668-59c0-e053-2a95a90a92c29
835603traMADol HCl 50 MG Oral TabletPSNf4ae0017-5050-4b92-9944-340385152b957
835603tramadol hydrochloride 50 MG Oral TabletSCDf4ae0017-5050-4b92-9944-340385152b957

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-229-126191902291212 TABLET in 1 BOTTLE (61919-229-12) 12 tablet2019-08-200000-00-00NoNoCurrent
61919-229-206191902292020 TABLET in 1 BOTTLE (61919-229-20) 20 tablet2014-01-010000-00-00NoNoCurrent
61919-229-306191902293030 TABLET in 1 BOTTLE (61919-229-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-229-406191902294040 TABLET in 1 BOTTLE (61919-229-40) 40 tablet2014-01-010000-00-00NoNoCurrent
61919-229-506191902295050 in 1 BOTTLEHistorical
61919-229-606191902296060 in 1 BOTTLEHistorical
61919-229-7161919022971100 TABLET in 1 BOTTLE (61919-229-71) 100 tablet2014-01-010000-00-00NoNoCurrent
61919-229-7261919022972120 in 1 BOTTLEHistorical
61919-229-8261919022982180 TABLET in 1 BOTTLE (61919-229-82) 180 tablet2014-01-010000-00-00NoNoCurrent
61919-229-8461919022984240 TABLET in 1 BOTTLE (61919-229-84) 240 tablet2019-08-200000-00-00NoNoCurrent
61919-229-906191902299090 BOTTLE in 1 BOTTLE (61919-229-90) > 120 BOTTLE in 1 BOTTLE (61919-229-72) > 60 BOTTLE in 1 BOTTLE (61919-229-60) > 50 BOTTLE in 1 BOTTLE (61919-229-50) > 30 TABLET in 1 BOTTLE (61919-229-30) 90 bottle2015-01-010000-00-00NoNoCurrent