FDA.reportPublic FDA data

tramadol hydrochloride

Product NDC
71335-2612
11-digit product format
713352612
Labeler code
71335
Product ID
71335-2612_064d5c7d-57b8-4bee-bcc6-739a2b2ad1b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202075
Marketing category
ANDA
Marketing start
2018-03-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
tramadol hydrochloride
Listing expiration
2027-12-31

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
71335-2612-1tramadol hydrochloride8 in 1 BOTTLETABLET8100
71335-2612-2tramadol hydrochloride84 in 1 BOTTLETABLET84100
71335-2612-3tramadol hydrochloride56 in 1 BOTTLETABLET56100
71335-2612-4tramadol hydrochloride10 in 1 BOTTLETABLET10100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNa886d551-6b57-4d9d-87f4-e1366385c7fd100
835603tramadol hydrochloride 50 MG Oral TabletSCDa886d551-6b57-4d9d-87f4-e1366385c7fd100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2612-1713352612018 TABLET in 1 BOTTLE (71335-2612-1) 8 tablet2026-03-11NoNoCurrent
71335-2612-27133526120284 TABLET in 1 BOTTLE (71335-2612-2) 84 tablet2026-03-11NoNoCurrent
71335-2612-37133526120356 TABLET in 1 BOTTLE (71335-2612-3) 56 tablet2026-03-11NoNoCurrent
71335-2612-47133526120410 TABLET in 1 BOTTLE (71335-2612-4) 10 tablet2026-03-11NoNoCurrent