FDA.reportPublic FDA data

tramadol hydrochloride

Product NDC
45865-115
11-digit product format
458650115
Labeler code
45865
Product ID
45865-115_b53300b2-8582-284c-e053-2995a90a83d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA075964
Marketing category
ANDA
Marketing start
2020-07-01
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
2021-12-31
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
45865-115-212025-01-30C16284748780-12cef2736-6381-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
45865-115-302025-01-30C16284748780-12cef2736-6381-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
45865-115-602025-01-30C16284748780-12cef2736-6381-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
45865-115-21tramadol hydrochloride21 in 1 BOTTLETABLET211
45865-115-30tramadol hydrochloride30 in 1 BOTTLETABLET301
45865-115-60tramadol hydrochloride60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-115TRAMADOL HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 3 package rows20201129_b533007a-ffe8-4de7-e053-2a95a90a1901.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNb533007a-ffe8-4de7-e053-2a95a90a19011
835603tramadol hydrochloride 50 MG Oral TabletSCDb533007a-ffe8-4de7-e053-2a95a90a19011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-115-214586501152121 TABLET in 1 BOTTLE (45865-115-21) 21 tablet2020-07-010000-00-00NoNoCurrent
45865-115-304586501153030 TABLET in 1 BOTTLE (45865-115-30) 30 tablet2020-07-010000-00-00NoNoCurrent
45865-115-604586501156060 TABLET in 1 BOTTLE (45865-115-60) 60 tablet2020-07-010000-00-00NoNoCurrent