tramadol hydrochloride

Product NDC
68071-5204
11-digit product format
680715204
Labeler code
68071
Product ID
68071-5204_dee79c9b-b495-2b98-e053-2a95a90a4756
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
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
68071-5204-3tramadol hydrochloride30 in 1 BOTTLETABLET307
68071-5204-4tramadol hydrochloride40 in 1 BOTTLETABLET407
68071-5204-5tramadol hydrochloride15 in 1 BOTTLETABLET157
68071-5204-8tramadol hydrochloride180 in 1 BOTTLETABLET1807
68071-5204-9tramadol hydrochloride90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5204TRAMADOL HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]7Legacy NDC, 5 package rows20240622_a0ad984a-38da-1fe0-e053-2995a90af23e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNa0ad984a-38da-1fe0-e053-2995a90af23e7
835603tramadol hydrochloride 50 MG Oral TabletSCDa0ad984a-38da-1fe0-e053-2995a90af23e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5204-36807152040330 TABLET in 1 BOTTLE (68071-5204-3) 30 tablet2020-03-120000-00-00NoNoCurrent
68071-5204-46807152040440 TABLET in 1 BOTTLE (68071-5204-4) 40 tablet2020-03-120000-00-00NoNoCurrent
68071-5204-56807152040515 TABLET in 1 BOTTLE (68071-5204-5) 15 tablet2020-03-120000-00-00NoNoCurrent
68071-5204-868071520408180 TABLET in 1 BOTTLE (68071-5204-8) 180 tablet2020-03-120000-00-00NoNoCurrent
68071-5204-96807152040990 TABLET in 1 BOTTLE (68071-5204-9) 90 tablet2020-03-120000-00-00NoNoCurrent