FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
71335-2721
11-digit product format
713352721
Labeler code
71335
Product ID
71335-2721_95a194c4-ed0a-4847-8722-30b3e5dff9dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208708
Marketing category
ANDA
Marketing start
2023-07-24
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
71335-2721-1Tramadol Hydrochloride8 in 1 BOTTLETABLET, COATED81
71335-2721-2Tramadol Hydrochloride84 in 1 BOTTLETABLET, COATED841
71335-2721-3Tramadol Hydrochloride56 in 1 BOTTLETABLET, COATED561
71335-2721-4Tramadol Hydrochloride10 in 1 BOTTLETABLET, COATED101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN2bf66203-8b45-475d-9a70-4d7c8bdfe6b31
835603tramadol hydrochloride 50 MG Oral TabletSCD2bf66203-8b45-475d-9a70-4d7c8bdfe6b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2721-1713352721018 TABLET, COATED in 1 BOTTLE (71335-2721-1) 2025-09-26NoNoCurrent
71335-2721-27133527210284 TABLET, COATED in 1 BOTTLE (71335-2721-2) 2025-09-26NoNoCurrent
71335-2721-37133527210356 TABLET, COATED in 1 BOTTLE (71335-2721-3) 2025-09-26NoNoCurrent
71335-2721-47133527210410 TABLET, COATED in 1 BOTTLE (71335-2721-4) 2025-09-26NoNoCurrent