Tramadol Hydrochloride

Product NDC
67296-0389
11-digit product format
672960389
Labeler code
67296
Product ID
67296-0389_3fcc00a9-6610-6568-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076003
Marketing category
ANDA
Marketing start
2010-11-15
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0389-1Tramadol Hydrochloride15 in 1 BOTTLETABLET154
67296-0389-2Tramadol Hydrochloride30 in 1 BOTTLETABLET304
67296-0389-3Tramadol Hydrochloride6 in 1 BOTTLETABLET64
67296-0389-4Tramadol Hydrochloride45 in 1 BOTTLETABLET454
67296-0389-5Tramadol Hydrochloride20 in 1 BOTTLETABLET204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0389TRAMADOL HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]4Legacy NDC, 5 package rows20161027_3fcc00a9-660f-6568-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN3fcc00a9-660f-6568-e054-00144ff88e884
835603tramadol hydrochloride 50 MG Oral TabletSCD3fcc00a9-660f-6568-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0389-16729603890115 in 1 BOTTLEHistorical
67296-0389-26729603890230 in 1 BOTTLEHistorical
67296-0389-3672960389036 in 1 BOTTLEHistorical
67296-0389-46729603890445 in 1 BOTTLEHistorical
67296-0389-56729603890520 in 1 BOTTLEHistorical