TRAMADOL HYDROCHLORIDE

Product NDC
61919-895
11-digit product format
619190895
Labeler code
61919
Product ID
61919-895_9cad6d5a-7942-9080-e053-2a95a90a9281
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078783
Marketing category
ANDA
Marketing start
2016-12-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
61919-895-302023-01-30C16284748780-1f386c649-ee21-0266-e053-dadaa90a7c1aTRAMADOL ER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-895-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-895TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]2Legacy NDC, 1 package rows20200122_429ff009-936b-1e4c-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN429ff009-936b-1e4c-e054-00144ff88e882
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD429ff009-936b-1e4c-e054-00144ff88e882
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY429ff009-936b-1e4c-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-895-306191908953030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-895-30) 2016-12-010000-00-00NoNoCurrent