FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
72189-311
11-digit product format
721890311
Labeler code
72189
Product ID
72189-311_2c3cf1d7-38f5-4d25-e063-6294a90aa8cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DirectRx
Application
ANDA208708
Marketing category
ANDA
Marketing start
2022-01-12
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

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
72189-311-12TRAMADOL HYDROCHLORIDE12 in 1 BOTTLETABLET, COATED126
72189-311-20TRAMADOL HYDROCHLORIDE20 in 1 BOTTLETABLET, COATED206
72189-311-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, COATED306
72189-311-40TRAMADOL HYDROCHLORIDE40 in 1 BOTTLETABLET, COATED406
72189-311-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, COATED606
72189-311-72TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET, COATED1206
72189-311-82TRAMADOL HYDROCHLORIDE180 in 1 BOTTLETABLET, COATED1806
72189-311-84TRAMADOL HYDROCHLORIDE240 in 1 BOTTLETABLET, COATED2406
72189-311-90TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-311TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECTRX]6Current NDC, Legacy NDC, 9 package rows20250122_d5685c80-c84d-d0a1-e053-2995a90afc54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNd5685c80-c84d-d0a1-e053-2995a90afc546
835603tramadol hydrochloride 50 MG Oral TabletSCDd5685c80-c84d-d0a1-e053-2995a90afc546

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-311-127218903111212 TABLET, COATED in 1 BOTTLE (72189-311-12) 2022-01-120000-00-00NoNoCurrent
72189-311-207218903112020 TABLET, COATED in 1 BOTTLE (72189-311-20) 2022-01-120000-00-00NoNoCurrent
72189-311-307218903113030 TABLET, COATED in 1 BOTTLE (72189-311-30) 2022-01-120000-00-00NoNoCurrent
72189-311-407218903114040 TABLET, COATED in 1 BOTTLE (72189-311-40) 2022-01-120000-00-00NoNoCurrent
72189-311-607218903116060 TABLET, COATED in 1 BOTTLE (72189-311-60) 2022-01-120000-00-00NoNoCurrent
72189-311-7272189031172120 TABLET, COATED in 1 BOTTLE (72189-311-72) 2022-01-120000-00-00NoNoCurrent
72189-311-8272189031182180 TABLET, COATED in 1 BOTTLE (72189-311-82) 2022-01-120000-00-00NoNoCurrent
72189-311-8472189031184240 TABLET, COATED in 1 BOTTLE (72189-311-84) 2022-01-12NoNoCurrent
72189-311-907218903119090 TABLET, COATED in 1 BOTTLE (72189-311-90) 2022-01-120000-00-00NoNoCurrent