TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC
68071-2831
11-digit product format
680712831
Labeler code
68071
Product ID
68071-2831_e8a56651-a291-7609-e053-2a95a90a7c36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077184
Marketing category
ANDA
Marketing start
2005-12-16
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
2023-12-31
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
68071-2831-2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2831TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220916_e8a55896-67f8-3d23-e053-2a95a90a654a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNe8a55896-67f8-3d23-e053-2a95a90a654a1
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDe8a55896-67f8-3d23-e053-2a95a90a654a1
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYe8a55896-67f8-3d23-e053-2a95a90a654a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2831-26807128310220 TABLET, FILM COATED in 1 BOTTLE (68071-2831-2) 2022-09-140000-00-00NoNoCurrent