tramadol hydrochloride

Product NDC
50436-0377
11-digit product format
504360377
Labeler code
50436
Product ID
50436-0377_68be38f8-e815-4448-895b-e4568b7fc97e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA075964
Marketing category
ANDA
Marketing start
2002-06-22
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
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0377-1tramadol hydrochloride30 in 1 BOTTLETABLET308
50436-0377-2tramadol hydrochloride60 in 1 BOTTLETABLET608
50436-0377-3tramadol hydrochloride90 in 1 BOTTLETABLET908
50436-0377-4tramadol hydrochloride50 in 1 BOTTLETABLET508
50436-0377-5tramadol hydrochloride120 in 1 BOTTLETABLET1208
50436-0377-6tramadol hydrochloride180 in 1 BOTTLETABLET1808
50436-0377-7tramadol hydrochloride240 in 1 BOTTLETABLET2408
50436-0377-8tramadol hydrochloride15 in 1 BOTTLETABLET158

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0377-8EA - Each50436-0377fedd60db-23e6-4dc0-9a78-8f1df33988ac12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0377TRAMADOL HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]8Legacy NDC, 8 package rows20180717_71118582-d521-4003-b18b-a7bf82c3d286.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN71118582-d521-4003-b18b-a7bf82c3d2868
835603tramadol hydrochloride 50 MG Oral TabletSCD71118582-d521-4003-b18b-a7bf82c3d2868

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0377-15043603770130 in 1 BOTTLEHistorical
50436-0377-25043603770260 in 1 BOTTLEHistorical
50436-0377-35043603770390 in 1 BOTTLEHistorical
50436-0377-45043603770450 in 1 BOTTLEHistorical
50436-0377-550436037705120 in 1 BOTTLEHistorical
50436-0377-650436037706180 in 1 BOTTLEHistorical
50436-0377-750436037707240 in 1 BOTTLEHistorical
50436-0377-85043603770815 in 1 BOTTLEHistorical