TRAMADOL HYDROCHLORIDE

Product NDC
71205-708
11-digit product format
712050708
Labeler code
71205
Product ID
71205-708_00b7f61b-5173-43e6-a3f9-d2efbda40c19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201384
Marketing category
ANDA
Marketing start
2011-12-12
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833711

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-708-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE301
71205-708-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE601
71205-708-90TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-708TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20221102_00b7f61b-5173-43e6-a3f9-d2efbda40c19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN00b7f61b-5173-43e6-a3f9-d2efbda40c191
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD00b7f61b-5173-43e6-a3f9-d2efbda40c191
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY00b7f61b-5173-43e6-a3f9-d2efbda40c191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-708-307120507083030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-708-30) 2022-10-310000-00-00NoNoCurrent
71205-708-607120507086060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-708-60) 2022-10-310000-00-00NoNoCurrent
71205-708-907120507089090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-708-90) 2022-10-310000-00-00NoNoCurrent