FDA.reportPublic FDA data

tramadol hydrochloride

Product NDC
67296-1021
11-digit product format
672961021
Labeler code
67296
Product ID
67296-1021_1cfead90-c8e9-3bb3-e063-6394a90a1090
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA075964
Marketing category
ANDA
Marketing start
2002-06-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
tramadol hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui835603

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
67296-1021-12024-07-11C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-22024-07-11C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-32024-07-11C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-42024-07-11C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-52024-07-11C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-62024-07-11C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-72024-07-11C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-12023-01-30C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-22023-01-30C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-32023-01-30C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-42023-01-30C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-52023-01-30C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-62023-01-30C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg
67296-1021-72023-01-30C16284748780-1f386c649-c32f-0266-e053-dadaa90a7c1atramadol 50mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1021-1tramadol hydrochloride10 in 1 BOTTLETABLET105
67296-1021-2tramadol hydrochloride20 in 1 BOTTLETABLET205
67296-1021-3tramadol hydrochloride30 in 1 BOTTLETABLET305
67296-1021-4tramadol hydrochloride45 in 1 BOTTLETABLET455
67296-1021-5tramadol hydrochloride15 in 1 BOTTLETABLET155
67296-1021-6tramadol hydrochloride6 in 1 BOTTLETABLET65
67296-1021-7tramadol hydrochloride40 in 1 BOTTLETABLET405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1021TRAMADOL HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]5Current NDC, Legacy NDC, 7 package rows20240712_4e2c0893-6faf-15ed-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN4e2c0893-6faf-15ed-e054-00144ff8d46c5
835603tramadol hydrochloride 50 MG Oral TabletSCD4e2c0893-6faf-15ed-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1021-16729610210110 TABLET in 1 BOTTLE (67296-1021-1) 10 tablet2002-06-220000-00-00NoNoCurrent
67296-1021-26729610210220 TABLET in 1 BOTTLE (67296-1021-2) 20 tablet2021-01-010000-00-00NoNoCurrent
67296-1021-36729610210330 TABLET in 1 BOTTLE (67296-1021-3) 30 tablet2002-06-220000-00-00NoNoCurrent
67296-1021-46729610210445 TABLET in 1 BOTTLE (67296-1021-4) 45 tablet2002-06-220000-00-00NoNoCurrent
67296-1021-56729610210515 TABLET in 1 BOTTLE (67296-1021-5) 15 tablet2002-06-220000-00-00NoNoCurrent
67296-1021-6672961021066 TABLET in 1 BOTTLE (67296-1021-6) 6 tablet2002-06-220000-00-00NoNoCurrent
67296-1021-76729610210740 TABLET in 1 BOTTLE (67296-1021-7) 40 tablet2021-01-010000-00-00NoNoCurrent