FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
72888-008
11-digit product format
728880008
Labeler code
72888
Product ID
72888-008_47c74a4e-51f2-e294-e063-6394a90aa70b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA208708
Marketing category
ANDA
Marketing start
2020-02-24
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui835603, 2179635, 2670390, 2692878

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
72888-008-00Tramadol Hydrochloride1000 in 1 BOTTLETABLET, COATED100014
72888-008-01Tramadol Hydrochloride100 in 1 BOTTLETABLET, COATED10014
72888-008-05Tramadol Hydrochloride500 in 1 BOTTLETABLET, COATED50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-008-01EA - Each72888-008c33c0000-441e-4155-9cda-d307d608a9d012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-008TRAMADOL HYDROCHLORIDE TABLET, COATED [ADVAGEN PHARMA LIMITED]12Current NDC, Legacy NDC, 3 package rows20240907_93b12089-3a0f-4b57-abb1-2429cf31995d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2179635traMADol HCl 100 MG Oral TabletPSN93b12089-3a0f-4b57-abb1-2429cf31995d14
835603traMADol HCl 50 MG Oral TabletPSN93b12089-3a0f-4b57-abb1-2429cf31995d14
2670390traMADol hydrochloride 25 MG Oral TabletPSN93b12089-3a0f-4b57-abb1-2429cf31995d14
2692878traMADol hydrochloride 75 MG Oral TabletPSN93b12089-3a0f-4b57-abb1-2429cf31995d14
2179635tramadol hydrochloride 100 MG Oral TabletSCD93b12089-3a0f-4b57-abb1-2429cf31995d14
2670390tramadol hydrochloride 25 MG Oral TabletSCD93b12089-3a0f-4b57-abb1-2429cf31995d14
835603tramadol hydrochloride 50 MG Oral TabletSCD93b12089-3a0f-4b57-abb1-2429cf31995d14
2692878tramadol hydrochloride 75 MG Oral TabletSCD93b12089-3a0f-4b57-abb1-2429cf31995d14
2179635tramadol HCl 100 MG Oral TabletSY93b12089-3a0f-4b57-abb1-2429cf31995d14
2179635traMADol HCl 100 MG Oral TabletPSN6a60bd36-7dcc-49c3-b6de-b263fdaa312c3
835603traMADol HCl 50 MG Oral TabletPSN6a60bd36-7dcc-49c3-b6de-b263fdaa312c3
2670390traMADol hydrochloride 25 MG Oral TabletPSN6a60bd36-7dcc-49c3-b6de-b263fdaa312c3
2179635tramadol hydrochloride 100 MG Oral TabletSCD6a60bd36-7dcc-49c3-b6de-b263fdaa312c3
2670390tramadol hydrochloride 25 MG Oral TabletSCD6a60bd36-7dcc-49c3-b6de-b263fdaa312c3
835603tramadol hydrochloride 50 MG Oral TabletSCD6a60bd36-7dcc-49c3-b6de-b263fdaa312c3
2179635tramadol HCl 100 MG Oral TabletSY6a60bd36-7dcc-49c3-b6de-b263fdaa312c3
835603traMADol HCl 50 MG Oral TabletPSN1261c32e-1b8c-75a8-e063-6294a90af4612
835603tramadol hydrochloride 50 MG Oral TabletSCD1261c32e-1b8c-75a8-e063-6294a90af4612
2179635traMADol HCl 100 MG Oral TabletPSN3135a131-5f2d-3775-e063-6394a90a43221
2179635traMADol HCl 100 MG Oral TabletPSN1e047b6c-7523-3619-e063-6394a90a03fc1
2179635tramadol hydrochloride 100 MG Oral TabletSCD3135a131-5f2d-3775-e063-6394a90a43221
2179635tramadol hydrochloride 100 MG Oral TabletSCD1e047b6c-7523-3619-e063-6394a90a03fc1
2179635tramadol HCl 100 MG Oral TabletSY3135a131-5f2d-3775-e063-6394a90a43221
2179635tramadol HCl 100 MG Oral TabletSY1e047b6c-7523-3619-e063-6394a90a03fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-008-00728880008001000 TABLET, COATED in 1 BOTTLE (72888-008-00) 2020-02-240000-00-00NoNoCurrent
72888-008-0172888000801100 TABLET, COATED in 1 BOTTLE (72888-008-01) 2020-02-240000-00-00NoNoCurrent
72888-008-0572888000805500 TABLET, COATED in 1 BOTTLE (72888-008-05) 2020-02-240000-00-00NoNoCurrent