FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
68788-8367
11-digit product format
687888367
Labeler code
68788
Product ID
68788-8367_1ba78592-5daf-4d80-ae65-c71d84b7a06e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA200503
Marketing category
ANDA
Marketing start
2023-02-01
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
68788-8367-2TRAMADOL HYDROCHLORIDE20 in 1 BOTTLETABLET, EXTENDED RELEASE203
68788-8367-3TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE303
68788-8367-6TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE603
68788-8367-9TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8367TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20240822_c30f6e9e-8014-40fc-9615-a6b8654137c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNc30f6e9e-8014-40fc-9615-a6b8654137c13
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDc30f6e9e-8014-40fc-9615-a6b8654137c13
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYc30f6e9e-8014-40fc-9615-a6b8654137c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8367-26878883670220 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-2) 2023-02-01NoNoCurrent
68788-8367-36878883670330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-3) 2023-02-01NoNoCurrent
68788-8367-66878883670660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-6) 2023-02-01NoNoCurrent
68788-8367-96878883670990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-9) 2023-02-01NoNoCurrent