FDA.reportPublic FDA data

tramadol hydrochloride

Product NDC
71093-119
11-digit product format
710930119
Labeler code
71093
Product ID
71093-119_ae4b6106-d5cc-4c50-818c-6a0f565dce4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ACI Healthcare USA, Inc.
Application
ANDA202075
Marketing category
ANDA
Marketing start
2018-03-01
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
71093-119-042026-01-29C16284748780-149896155-c27d-586f-e063-e6dba90add90These 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
71093-119-052026-01-29C16284748780-149896155-c27d-586f-e063-e6dba90add90These 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
71093-119-062026-01-29C16284748780-149896155-c27d-586f-e063-e6dba90add90These 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
71093-119-04tramadol hydrochloride100 in 1 BOTTLETABLET10010
71093-119-05tramadol hydrochloride500 in 1 PACKAGETABLET50010
71093-119-06tramadol hydrochloride1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-119-04EA - Each71093-11914d9dd0d-70ae-4014-a369-35a8ca3dd1e212021-07-15
71093-119-05EA - Each71093-119b02afa4f-4433-4a24-9b16-4505095ec25c12023-05-05
71093-119-06EA - Each71093-119b3941d93-2810-44ae-9ce1-1d2adcc1dd1e12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-119TRAMADOL HYDROCHLORIDE TABLET [ACI HEALTHCARE USA, INC.]10Legacy NDC, 3 package rows20231217_f3c7d874-8f9e-4687-9dac-2356ecfa86f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNa886d551-6b57-4d9d-87f4-e1366385c7fd100
835603tramadol hydrochloride 50 MG Oral TabletSCDa886d551-6b57-4d9d-87f4-e1366385c7fd100
835603traMADol HCl 50 MG Oral TabletPSNf3c7d874-8f9e-4687-9dac-2356ecfa86f910
835603tramadol hydrochloride 50 MG Oral TabletSCDf3c7d874-8f9e-4687-9dac-2356ecfa86f910
835603traMADol HCl 50 MG Oral TabletPSN087a7afe-ac1f-a201-e063-6394a90a260d5
835603traMADol HCl 50 MG Oral TabletPSN1cd3caee-bf54-7aba-e063-6394a90ad8cb5
835603tramadol hydrochloride 50 MG Oral TabletSCD087a7afe-ac1f-a201-e063-6394a90a260d5
835603tramadol hydrochloride 50 MG Oral TabletSCD1cd3caee-bf54-7aba-e063-6394a90ad8cb5
835603traMADol HCl 50 MG Oral TabletPSN1e79e1fa-3473-f4a7-e063-6294a90a95764
835603tramadol hydrochloride 50 MG Oral TabletSCD1e79e1fa-3473-f4a7-e063-6294a90a95764
835603traMADol HCl 50 MG Oral TabletPSN1b5360f8-3e95-a047-e063-6294a90a73152
835603traMADol HCl 50 MG Oral TabletPSN0b3bac7c-59d2-0261-e063-6294a90a0a572
835603traMADol HCl 50 MG Oral TabletPSNc6104e62-5b2c-41a1-afb3-00dcf267a3842
835603traMADol HCl 50 MG Oral TabletPSN05f8e06b-f3eb-4cb2-aee5-bd0b038841782
835603tramadol hydrochloride 50 MG Oral TabletSCD1b5360f8-3e95-a047-e063-6294a90a73152
835603tramadol hydrochloride 50 MG Oral TabletSCD05f8e06b-f3eb-4cb2-aee5-bd0b038841782
835603tramadol hydrochloride 50 MG Oral TabletSCDc6104e62-5b2c-41a1-afb3-00dcf267a3842
835603tramadol hydrochloride 50 MG Oral TabletSCD0b3bac7c-59d2-0261-e063-6294a90a0a572
835603traMADol HCl 50 MG Oral TabletPSN1e0467c7-58de-9ccf-e063-6294a90aaed61
835603traMADol HCl 50 MG Oral TabletPSN2236031d-8596-4c21-8b16-83aa3e4122c11
835603traMADol HCl 50 MG Oral TabletPSN6ebc5864-c222-4400-a9b2-f66fd6fb0da61
835603tramadol hydrochloride 50 MG Oral TabletSCD1e0467c7-58de-9ccf-e063-6294a90aaed61
835603tramadol hydrochloride 50 MG Oral TabletSCD2236031d-8596-4c21-8b16-83aa3e4122c11
835603tramadol hydrochloride 50 MG Oral TabletSCD6ebc5864-c222-4400-a9b2-f66fd6fb0da61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71093-119-0471093011904100 TABLET in 1 BOTTLE (71093-119-04) 100 tablet2018-03-010000-00-00NoNoCurrent
71093-119-0571093011905500 TABLET in 1 PACKAGE (71093-119-05) 500 tablet2022-12-040000-00-00NoNoCurrent
71093-119-06710930119061000 TABLET in 1 BOTTLE (71093-119-06) 1000 tablet2018-03-010000-00-00NoNoCurrent