FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
63629-8324
11-digit product format
636298324
Labeler code
63629
Product ID
63629-8324_a9b37df0-5fce-4e74-8ca9-92b722fc5293
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201384
Marketing category
ANDA
Marketing start
2011-12-12
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
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 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
63629-8324-1TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE301006
63629-8324-2TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE601006
63629-8324-3TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE901006
63629-8324-4TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE1201006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8324TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1005Current NDC, Legacy NDC, 4 package rows20240511_a77b0dba-8ac7-418a-b435-16a0e6c22804.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNa77b0dba-8ac7-418a-b435-16a0e6c228041006
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDa77b0dba-8ac7-418a-b435-16a0e6c228041006
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSYa77b0dba-8ac7-418a-b435-16a0e6c228041006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8324-16362983240130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-1) 2020-06-220000-00-00NoNoCurrent
63629-8324-26362983240260 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-2) 2021-10-040000-00-00NoNoCurrent
63629-8324-36362983240390 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-3) 2024-04-030000-00-00NoNoCurrent
63629-8324-463629832404120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-4) 2024-04-030000-00-00NoNoCurrent