FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
71205-463
11-digit product format
712050463
Labeler code
71205
Product ID
71205-463_77acc237-26cc-4dbd-a211-cad637a0b6ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200503
Marketing category
ANDA
Marketing start
2014-08-19
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
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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833709

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
71205-463-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71205-463-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71205-463-90TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-463TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220409_f63facd7-519b-4e2b-b54f-c17fc9ede55f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNf63facd7-519b-4e2b-b54f-c17fc9ede55f2
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDf63facd7-519b-4e2b-b54f-c17fc9ede55f2
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYf63facd7-519b-4e2b-b54f-c17fc9ede55f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-463-307120504633030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-463-30) 2020-07-210000-00-00NoNoCurrent
71205-463-607120504636060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-463-60) 2020-07-210000-00-00NoNoCurrent
71205-463-907120504639090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-463-90) 2020-07-210000-00-00NoNoCurrent