FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
72189-382
11-digit product format
721890382
Labeler code
72189
Product ID
72189-382_2c4cd58a-0293-714d-e063-6394a90a5edd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA207152
Marketing category
ANDA
Marketing start
2022-09-14
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol Hydrochloride and Acetaminophen
Listing expiration
2026-12-31

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
72189-382-60Tramadol Hydrochloride and Acetaminophen60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-382-60EA - Each72189-382fd089fda-1e82-4e5c-a583-a26bba4cb2ba12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-382TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20250123_e8a7c995-e473-ca87-e053-2995a90a5b80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNe8a7c995-e473-ca87-e053-2995a90a5b802
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDe8a7c995-e473-ca87-e053-2995a90a5b802
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYe8a7c995-e473-ca87-e053-2995a90a5b802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-382-607218903826060 TABLET, FILM COATED in 1 BOTTLE (72189-382-60) 2022-09-140000-00-00NoNoCurrent