FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
71205-569
11-digit product format
712050569
Labeler code
71205
Product ID
71205-569_f234949f-7ee3-4778-9875-4c3ce51e8b38
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
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
Rxcui833713

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
71205-569-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71205-569-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71205-569-90TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-569-30EA - Each71205-5697a71571d-56d3-45ae-950d-df9cafbe0e3d12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-569TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220710_3c187736-ea96-4e59-9fe6-cb625a619c63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSN3c187736-ea96-4e59-9fe6-cb625a619c632
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCD3c187736-ea96-4e59-9fe6-cb625a619c632
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSY3c187736-ea96-4e59-9fe6-cb625a619c632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-569-307120505693030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-569-30) 2021-05-260000-00-00NoNoCurrent
71205-569-607120505696060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-569-60) 2021-05-260000-00-00NoNoCurrent
71205-569-907120505699090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-569-90) 2021-05-260000-00-00NoNoCurrent