FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
53217-180
11-digit product format
532170180
Labeler code
53217
Product ID
53217-180_635e7ce5-287c-458f-946d-39889fadc64d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA090460
Marketing category
ANDA
Marketing start
2012-10-15
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
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
53217-180-202020-01-31C16284748780-19d75b9d0-adbf-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP
53217-180-302020-01-31C16284748780-19d75b9d0-adbf-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP
53217-180-602020-01-31C16284748780-19d75b9d0-adbf-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP
53217-180-902020-01-31C16284748780-19d75b9d0-adbf-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-180-20Tramadol Hydrochloride and Acetaminophen20 in 1 BOTTLETABLET, FILM COATED201
53217-180-30Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET, FILM COATED301
53217-180-60Tramadol Hydrochloride and Acetaminophen60 in 1 BOTTLETABLET, FILM COATED601
53217-180-90Tramadol Hydrochloride and Acetaminophen90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-180-20EA - Each53217-1805dd77f38-586e-487c-82be-73182526ec3f12017-03-06
53217-180-30EA - Each53217-180a6f3d902-ff84-4fb5-89bc-223466ceb14c12017-03-06
53217-180-60EA - Each53217-18064b34ca5-cccf-4411-89e5-f2dd257ab03c12017-03-06
53217-180-90EA - Each53217-1807bfe1d9b-efbd-4849-ac25-b811443ca93e12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-180TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20170302_9970e094-96c4-4dab-97aa-40502455ca76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN9970e094-96c4-4dab-97aa-40502455ca761
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD9970e094-96c4-4dab-97aa-40502455ca761
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY9970e094-96c4-4dab-97aa-40502455ca761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-180-205321701802020 in 1 BOTTLEHistorical
53217-180-305321701803030 in 1 BOTTLEHistorical
53217-180-605321701806060 in 1 BOTTLEHistorical
53217-180-905321701809090 in 1 BOTTLEHistorical