FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
72189-154
11-digit product format
721890154
Labeler code
72189
Product ID
72189-154_2be91ca4-b100-8b02-e063-6294a90a3c24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA200503
Marketing category
ANDA
Marketing start
2020-11-10
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833711

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
72189-154-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE304
72189-154-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-154TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]4Current NDC, Legacy NDC, 2 package rows20250119_b3c702f7-0a8c-a52b-e053-2995a90a6df3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNb3c702f7-0a8c-a52b-e053-2995a90a6df34
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDb3c702f7-0a8c-a52b-e053-2995a90a6df34
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYb3c702f7-0a8c-a52b-e053-2995a90a6df34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-154-307218901543030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-154-30) 2020-11-100000-00-00NoNoCurrent
72189-154-607218901546060 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-154-60) 2020-11-10NoNoCurrent