FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
68071-2410
11-digit product format
680712410
Labeler code
68071
Product ID
68071-2410_c2db702a-b47d-27af-e053-2995a90ac057
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA200503
Marketing category
ANDA
Marketing start
2014-08-19
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
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
68071-2410-62023-01-30C16284748780-1f386c649-bacc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use 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
68071-2410-6TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2410TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20210522_c2db6902-118d-58c2-e053-2a95a90ac308.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNc2db6902-118d-58c2-e053-2a95a90ac3081
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDc2db6902-118d-58c2-e053-2a95a90ac3081
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYc2db6902-118d-58c2-e053-2a95a90ac3081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2410-66807124100660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2410-6) 2021-05-210000-00-00NoNoCurrent