FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
33342-271
11-digit product format
333420271
Labeler code
33342
Product ID
33342-271_0f59cb5b-586f-41de-866f-e2386f4d0178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA209404
Marketing category
ANDA
Marketing start
2025-01-31
Substance
TRAMADOL HYDROCHLORIDE
Active strength
300 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 HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833709, 833711, 833713

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
33342-271-07Tramadol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304
33342-271-10Tramadol Hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904
33342-271-11Tramadol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSYa07ed444-54e4-4d45-b6a1-6ea2f6dedc614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-271-073334202710730 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-07) 2025-01-31NoNoCurrent
33342-271-103334202711090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-10) 2025-01-31NoNoCurrent
33342-271-1133342027111100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-11) 2025-01-31NoNoCurrent