FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
63629-8323
11-digit product format
636298323
Labeler code
63629
Product ID
63629-8323_1bb0af50-74d6-49a3-b954-760eadfe4bf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-8323-1TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE30105
63629-8323-2TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE60105
63629-8323-3TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE90105
63629-8323-4TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE120105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8323TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 4 package rows20240830_8cc09b31-6067-44ec-8aba-ea7bb1a1f448.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN8cc09b31-6067-44ec-8aba-ea7bb1a1f448105
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD8cc09b31-6067-44ec-8aba-ea7bb1a1f448105
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY8cc09b31-6067-44ec-8aba-ea7bb1a1f448105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8323-16362983230130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8323-1) 2020-07-010000-00-00NoNoCurrent
63629-8323-26362983230260 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8323-2) 2020-06-010000-00-00NoNoCurrent
63629-8323-36362983230390 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8323-3) 2021-04-160000-00-00NoNoCurrent
63629-8323-463629832304120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8323-4) 2024-04-030000-00-00NoNoCurrent