Tramadol Hydrochloride

Product NDC
50090-5790
11-digit product format
500905790
Labeler code
50090
Product ID
50090-5790_831d953a-7e6c-42ca-a018-41a5a62429dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211825
Marketing category
ANDA
Marketing start
2019-08-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui835603

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5790-1Tramadol Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9017
50090-5790-2Tramadol Hydrochloride10 in 1 BOTTLETABLET, FILM COATED1017
50090-5790-3Tramadol Hydrochloride180 in 1 BOTTLETABLET, FILM COATED18017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5790TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 3 package rows20240604_4a525cf7-2c0c-47c6-aed3-3a395a7120ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN4a525cf7-2c0c-47c6-aed3-3a395a7120ec17
835603tramadol hydrochloride 50 MG Oral TabletSCD4a525cf7-2c0c-47c6-aed3-3a395a7120ec17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5790-15009057900190 TABLET, FILM COATED in 1 BOTTLE (50090-5790-1) 2022-02-080000-00-00NoNoCurrent
50090-5790-25009057900210 TABLET, FILM COATED in 1 BOTTLE (50090-5790-2) 2021-10-080000-00-00NoNoCurrent
50090-5790-350090579003180 TABLET, FILM COATED in 1 BOTTLE (50090-5790-3) 2022-06-290000-00-00NoNoCurrent