TRAMADOL HYDROCHLORIDE

Product NDC
58118-0319
11-digit product format
581180319
Labeler code
58118
Product ID
58118-0319_8d8185b4-14f8-48e9-e053-2995a90a94ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA090404
Marketing category
ANDA
Marketing start
2019-02-15
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
2020-12-31
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
58118-0319-82021-01-29C16284748780-1ba0f9c33-5081-a910-e053-dadaa90a0b85Tramadol Hydrochloride Tablets, USP C-IV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58118-0319-8TRAMADOL HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0319TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]2Legacy NDC, 1 package rows20190713_dadfad5d-4643-46f3-a329-c58c7b22ea35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNdadfad5d-4643-46f3-a329-c58c7b22ea352
835603tramadol hydrochloride 50 MG Oral TabletSCDdadfad5d-4643-46f3-a329-c58c7b22ea352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58118-0319-85811803190830 in 1 BLISTER PACKHistorical