FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
50090-4717
11-digit product format
500904717
Labeler code
50090
Product ID
50090-4717_fc08fb3b-d5cb-4257-8b54-321447dd975b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091498
Marketing category
ANDA
Marketing start
2015-05-22
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
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
50090-4717-12023-01-30C16284748780-1f386c649-ec9d-0266-e053-dadaa90a7c1aThese 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, CIV Initial U.S. Approval: 1995
50090-4717-22023-01-30C16284748780-1f386c649-ec9d-0266-e053-dadaa90a7c1aThese 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, CIV Initial U.S. Approval: 1995
50090-4717-32023-01-30C16284748780-1f386c649-ec9d-0266-e053-dadaa90a7c1aThese 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, CIV Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4717-1TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED902
50090-4717-2TRAMADOL HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED102
50090-4717-3TRAMADOL HYDROCHLORIDE180 in 1 BOTTLETABLET, FILM COATED1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4717TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Legacy NDC, 3 package rows20210303_de66ea8a-f320-483d-a429-724c9b65994e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNde66ea8a-f320-483d-a429-724c9b65994e2
835603tramadol hydrochloride 50 MG Oral TabletSCDde66ea8a-f320-483d-a429-724c9b65994e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4717-15009047170190 TABLET, FILM COATED in 1 BOTTLE (50090-4717-1) 2019-11-130000-00-00NoNoCurrent
50090-4717-25009047170210 TABLET, FILM COATED in 1 BOTTLE (50090-4717-2) 2019-11-130000-00-00NoNoCurrent
50090-4717-350090471703180 TABLET, FILM COATED in 1 BOTTLE (50090-4717-3) 2019-11-130000-00-00NoNoCurrent