TRAMADOL HYDROCHLORIDE

Product NDC
67296-1649
11-digit product format
672961649
Labeler code
67296
Product ID
67296-1649_b8df8cb5-10a1-58db-e053-2a95a90a8313
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA090404
Marketing category
ANDA
Marketing start
2019-01-01
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
67296-1649-12023-01-30C16284748780-1f386c649-9a68-0266-e053-dadaa90a7c1aTramadol 50mg
67296-1649-32023-01-30C16284748780-1f386c649-9a68-0266-e053-dadaa90a7c1aTramadol 50mg
67296-1649-62023-01-30C16284748780-1f386c649-9a68-0266-e053-dadaa90a7c1aTramadol 50mg
67296-1649-72023-01-30C16284748780-1f386c649-9a68-0266-e053-dadaa90a7c1aTramadol 50mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1649-1TRAMADOL HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED1010
67296-1649-3TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3010
67296-1649-6TRAMADOL HYDROCHLORIDE6 in 1 BOTTLETABLET, FILM COATED610
67296-1649-7TRAMADOL HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED1510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1649TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]10Legacy NDC, 4 package rows20210115_8907b1f3-d238-695b-e053-2995a90aaa51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN8907b1f3-d238-695b-e053-2995a90aaa5110
835603tramadol hydrochloride 50 MG Oral TabletSCD8907b1f3-d238-695b-e053-2995a90aaa5110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1649-16729616490110 TABLET, FILM COATED in 1 BOTTLE (67296-1649-1) 2019-01-010000-00-00NoNoCurrent
67296-1649-36729616490330 TABLET, FILM COATED in 1 BOTTLE (67296-1649-3) 2019-01-010000-00-00NoNoCurrent
67296-1649-6672961649066 TABLET, FILM COATED in 1 BOTTLE (67296-1649-6) 2019-01-010000-00-00NoNoCurrent
67296-1649-76729616490715 TABLET, FILM COATED in 1 BOTTLE (67296-1649-7) 2019-01-010000-00-00NoNoCurrent