FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
67296-1834
11-digit product format
672961834
Labeler code
67296
Product ID
67296-1834_4387f592-853f-01ea-e063-6394a90a6a4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
RedPharm Drug Inc
Application
ANDA208708
Marketing category
ANDA
Marketing start
2021-04-22
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1834-1Tramadol Hydrochloride10 in 1 BOTTLETABLET, COATED104
67296-1834-2Tramadol Hydrochloride20 in 1 BOTTLETABLET, COATED204
67296-1834-3Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED304
67296-1834-4Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED404
67296-1834-6Tramadol Hydrochloride6 in 1 BOTTLETABLET, COATED64
67296-1834-7Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1834TRAMADOL HYDROCHLORIDE TABLET, COATED [REDPHARM DRUG INC]2Current NDC, 6 package rows20240719_f4c148f3-845a-61e3-e053-2a95a90a326e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNf4c148f3-845a-61e3-e053-2a95a90a326e4
835603tramadol hydrochloride 50 MG Oral TabletSCDf4c148f3-845a-61e3-e053-2a95a90a326e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67296-1834-16729618340110 TABLET, COATED in 1 BOTTLE (67296-1834-1) 2021-04-22NoNoHistorical
67296-1834-26729618340220 TABLET, COATED in 1 BOTTLE (67296-1834-2) 2021-04-22NoNoHistorical
67296-1834-36729618340330 TABLET, COATED in 1 BOTTLE (67296-1834-3) 2021-04-22NoNoHistorical
67296-1834-46729618340440 TABLET, COATED in 1 BOTTLE (67296-1834-4) 2021-04-22NoNoHistorical
67296-1834-6672961834066 TABLET, COATED in 1 BOTTLE (67296-1834-6) 2021-04-22NoNoHistorical
67296-1834-76729618340715 TABLET, COATED in 1 BOTTLE (67296-1834-7) 2021-04-22NoNoHistorical