FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
52817-195
11-digit product format
528170195
Labeler code
52817
Product ID
52817-195_bb37b29d-c827-d710-e053-2995a90acf1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TRUPHARMA LLC
Application
ANDA208708
Marketing category
ANDA
Marketing start
2020-09-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui835603, 2179635

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
52817-195-00Tramadol Hydrochloride1000 in 1 BOTTLETABLET, COATED10004
52817-195-10Tramadol Hydrochloride100 in 1 BOTTLETABLET, COATED1004
52817-195-50Tramadol Hydrochloride500 in 1 BOTTLETABLET, COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-195TRAMADOL HYDROCHLORIDE TABLET, COATED [TRUPHARMA LLC]4Current NDC, Legacy NDC, 3 package rows20210214_61fb5ba7-6896-4ee4-83de-caee69b06a8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2179635traMADol HCl 100 MG Oral TabletPSN61fb5ba7-6896-4ee4-83de-caee69b06a8e4
835603traMADol HCl 50 MG Oral TabletPSN61fb5ba7-6896-4ee4-83de-caee69b06a8e4
2179635tramadol hydrochloride 100 MG Oral TabletSCD61fb5ba7-6896-4ee4-83de-caee69b06a8e4
835603tramadol hydrochloride 50 MG Oral TabletSCD61fb5ba7-6896-4ee4-83de-caee69b06a8e4
2179635tramadol HCl 100 MG Oral TabletSY61fb5ba7-6896-4ee4-83de-caee69b06a8e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-195-00528170195001000 TABLET, COATED in 1 BOTTLE (52817-195-00) 2020-09-010000-00-00NoNoCurrent
52817-195-1052817019510100 TABLET, COATED in 1 BOTTLE (52817-195-10) 2020-09-010000-00-00NoNoCurrent
52817-195-5052817019550500 TABLET, COATED in 1 BOTTLE (52817-195-50) 2020-09-010000-00-00NoNoCurrent