FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
68071-2351
11-digit product format
680712351
Labeler code
68071
Product ID
68071-2351_ea64909a-063d-a08f-e053-2995a90a07c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207152
Marketing category
ANDA
Marketing start
2017-03-22
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength
325 mg/1; 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
68071-2351-12025-01-30C16284748780-12cef2736-8692-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, CIV Initial U.S. Approval – 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2351-1Tramadol Hydrochloride and Acetaminophen16 in 1 BOTTLETABLET, FILM COATED162

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2351TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20221008_bb9e87d4-3598-8caa-e053-2a95a90ac6d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNbb9e87d4-3598-8caa-e053-2a95a90ac6d02
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDbb9e87d4-3598-8caa-e053-2a95a90ac6d02
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYbb9e87d4-3598-8caa-e053-2a95a90ac6d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2351-16807123510116 TABLET, FILM COATED in 1 BOTTLE (68071-2351-1) 2021-02-180000-00-00NoNoCurrent