FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC
50090-3705
11-digit product format
500903705
Labeler code
50090
Product ID
50090-3705_51054470-fbb4-48a2-a939-192e99cbb3b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077184
Marketing category
ANDA
Marketing start
2005-12-16
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength
38 mg/1; 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
50090-3705-02023-01-30C16284748780-1f386c64a-29ff-0266-e053-dadaa90a7c1aThese 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, C-IV Initial U.S. Approval: 2001
50090-3705-22023-01-30C16284748780-1f386c64a-29ff-0266-e053-dadaa90a7c1aThese 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, C-IV Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3705-0TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN20 in 1 BOTTLETABLET, FILM COATED204
50090-3705-2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3705TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20190430_62be65c6-8c8a-4c29-ae6e-1f1a5b89d1ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN62be65c6-8c8a-4c29-ae6e-1f1a5b89d1ce4
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD62be65c6-8c8a-4c29-ae6e-1f1a5b89d1ce4
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY62be65c6-8c8a-4c29-ae6e-1f1a5b89d1ce4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3705-05009037050020 TABLET, FILM COATED in 1 BOTTLE (50090-3705-0) 2018-10-220000-00-00NoNoCurrent
50090-3705-25009037050260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3705-2) 2014-11-280000-00-00NoNoCurrent