Tramadol Hydrochloride

Product NDC
69150-020
11-digit product format
691500020
Labeler code
69150
Product ID
69150-020_535b1232-f479-4ed2-bb13-f7d049c5a638
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
BIOMES PHARMACEUTICALS LLC
Application
ANDA202075
Marketing category
ANDA
Marketing start
2016-02-25
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
E
Listing certified through
2018-12-31
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
69150-020-102020-01-31C16284748780-19d75b9d1-0e88-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE TABLETS USP CIV Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69150-020-10Tramadol Hydrochloride1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69150-020-10EA - Each69150-020ce95d949-9e77-4876-a511-f2dd97e4408712016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69150-020TRAMADOL HYDROCHLORIDE TABLET [BIOMES PHARMACEUTICALS LLC]3Legacy NDC, 1 package rows20160311_2993f70d-2359-443e-8d7b-68de5332f708.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN2993f70d-2359-443e-8d7b-68de5332f7083
835603tramadol hydrochloride 50 MG Oral TabletSCD2993f70d-2359-443e-8d7b-68de5332f7083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69150-020-10691500020101000 in 1 BOTTLEHistorical