FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
70518-0942
11-digit product format
705180942
Labeler code
70518
Product ID
70518-0942_4d3ab233-15e7-e8a1-e063-6394a90ab1ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200503
Marketing category
ANDA
Marketing start
2018-01-09
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRAMADOL HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833709

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
70518-0942-0TRAMADOL HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3023
70518-0942-1TRAMADOL HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9023
70518-0942-2TRAMADOL HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE6023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0942TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 3 package rows20250504_16053b28-c759-4914-93e6-2de0afe72445.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN16053b28-c759-4914-93e6-2de0afe7244523
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD16053b28-c759-4914-93e6-2de0afe7244523
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY16053b28-c759-4914-93e6-2de0afe7244523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0942-07051809420030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0942-0) 2018-01-090000-00-00NoNoCurrent
70518-0942-17051809420190 in 1 BOTTLE, PLASTICHistorical
70518-0942-27051809420260 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0942-2) 2024-07-10NoNoCurrent