FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
45865-900
11-digit product format
458650900
Labeler code
45865
Product ID
45865-900_7d6438eb-89e6-6171-e053-2991aa0aa8bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA201384
Marketing category
ANDA
Marketing start
2011-12-12
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
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
45865-900-302025-01-30C16284748780-12cef2736-8ae4-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use children who developed life-threatening respiratory depression or died after taking tramadol for pain relief TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS. TRAMADOL HYDROCHLORIDE extended-release tablets for oral use, C IV Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-900-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-900TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20181220_7d641da7-1a42-187b-e053-2991aa0afd4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN7d641da7-1a42-187b-e053-2991aa0afd4b2
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD7d641da7-1a42-187b-e053-2991aa0afd4b2
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY7d641da7-1a42-187b-e053-2991aa0afd4b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-900-304586509003030 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-900-30) 2018-06-010000-00-00NoNoCurrent