Tramadol Hydrochloride

Product NDC
50090-3000
11-digit product format
500903000
Labeler code
50090
Product ID
50090-3000_6f0833a7-aca6-474a-aa91-74ce82c1c0bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076003
Marketing category
ANDA
Marketing start
2010-11-15
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
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
50090-3000-02020-01-31C16284748780-19d75b9d0-36fd-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV (50 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3000-0Tramadol Hydrochloride33 in 1 BOX, UNIT-DOSETABLET, COATED335
50090-3000-0Tramadol Hydrochloride1 in 1 BLISTER PACKTABLET, COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3000-0EA - Each50090-3000cb0df255-8cf4-4178-a593-d23b5fe360b412019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3000TRAMADOL HYDROCHLORIDE TABLET, COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20180821_402ff644-9f7b-46f3-b62c-d0f031575a40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN402ff644-9f7b-46f3-b62c-d0f031575a405
835603tramadol hydrochloride 50 MG Oral TabletSCD402ff644-9f7b-46f3-b62c-d0f031575a405

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3000-05009030000033 in 1 BOX, UNIT-DOSEHistorical