FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
50436-0698
11-digit product format
504360698
Labeler code
50436
Product ID
50436-0698_c156f766-a539-4db6-8c12-aea5057e6ad1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA200503
Marketing category
ANDA
Marketing start
2014-08-19
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 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
50436-0698-12023-01-30C16284748780-1f386c64a-3c9e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS. TRAMADOL hydrochloride extended-release tablets for oral use, C IV Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0698-1TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0698-1EA - Each50436-06987875f040-4b26-4fc0-927a-fe552e6dc0c612021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0698TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20211106_be15cd5f-055a-471f-8d24-c20d86fdc983.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNbe15cd5f-055a-471f-8d24-c20d86fdc9832
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDbe15cd5f-055a-471f-8d24-c20d86fdc9832
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYbe15cd5f-055a-471f-8d24-c20d86fdc9832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0698-15043606980130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50436-0698-1) 2021-11-010000-00-00NoNoCurrent