FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
72162-2510
11-digit product format
721622510
Labeler code
72162
Product ID
72162-2510_c303c3cf-8061-4da4-9d7b-f3a819e660c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207152
Marketing category
ANDA
Marketing start
2017-03-22
Substance
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength
325; 37.5 mg/1; 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 and Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
TRAMADOL HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9N7R477WCK
Rxcui836395

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
72162-2510-1Tramadol Hydrochloride and Acetaminophen100 in 1 BOTTLETABLET, FILM COATED100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2510-1EA - Each72162-25100bcdeb2e-a9a0-4193-bef9-4f2caa8e9f5212025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2510TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20250525_c83366d9-db60-45eb-9c2b-a2c58d45c82c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNc83366d9-db60-45eb-9c2b-a2c58d45c82c101
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDc83366d9-db60-45eb-9c2b-a2c58d45c82c101
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYc83366d9-db60-45eb-9c2b-a2c58d45c82c101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2510-172162251001100 TABLET, FILM COATED in 1 BOTTLE (72162-2510-1) 2017-03-22NoNoHistorical