TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC
61919-230
11-digit product format
619190230
Labeler code
61919
Product ID
61919-230_9cad680b-8399-909f-e053-2a95a90afc04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090485
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength
38 mg/1; 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
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
61919-230-302023-01-30C16284748780-1f386c649-f115-0266-e053-dadaa90a7c1aTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-230-30TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-230TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]3Legacy NDC, 1 package rows20200131_7613ef1c-9cdb-41aa-99f9-2355851f74a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN7613ef1c-9cdb-41aa-99f9-2355851f74a63
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD7613ef1c-9cdb-41aa-99f9-2355851f74a63
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY7613ef1c-9cdb-41aa-99f9-2355851f74a63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-230-306191902303030 TABLET in 1 BOTTLE (61919-230-30) 30 tablet2015-01-010000-00-00NoNoCurrent