FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
42254-051
11-digit product format
422540051
Labeler code
42254
Product ID
42254-051_6ddf4f5b-b6bb-4a15-a621-cd327d27ec53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA090485
Marketing category
ANDA
Marketing start
2009-12-17
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength
38 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-051-122019-09-24C16284748780-19350213a-3bea-c013-e053-90daa90a1393Tramadol Hydrochloride and Acetaminophen Tablets
42254-051-302019-09-24C16284748780-19350213a-3bea-c013-e053-90daa90a1393Tramadol Hydrochloride and Acetaminophen Tablets
42254-051-602019-09-24C16284748780-19350213a-3bea-c013-e053-90daa90a1393Tramadol Hydrochloride and Acetaminophen Tablets
42254-051-902019-09-24C16284748780-19350213a-3bea-c013-e053-90daa90a1393Tramadol Hydrochloride and Acetaminophen Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-051-12Tramadol Hydrochloride and Acetaminophen12 in 1 BOTTLETABLET121
42254-051-30Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET301
42254-051-60Tramadol Hydrochloride and Acetaminophen60 in 1 BOTTLETABLET601
42254-051-90Tramadol Hydrochloride and Acetaminophen90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-051-12EA - Each42254-051852b6dcc-df6c-4a27-a9cf-5dce5e93c53712012-07-24
42254-051-30EA - Each42254-0517d2bbbb6-b269-461e-a14a-daeef77ac99b12012-07-24
42254-051-60EA - Each42254-051c5193165-34ee-4739-9ed1-5ea87a3795b512012-07-24
42254-051-90EA - Each42254-051c72990c0-7f53-427b-8cd7-8ea66daeef6a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-051TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20120411_6ddf4f5b-b6bb-4a15-a621-cd327d27ec53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN6ddf4f5b-b6bb-4a15-a621-cd327d27ec531
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD6ddf4f5b-b6bb-4a15-a621-cd327d27ec531
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY6ddf4f5b-b6bb-4a15-a621-cd327d27ec531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-051-124225400511212 in 1 BOTTLEHistorical
42254-051-304225400513030 in 1 BOTTLEHistorical
42254-051-604225400516060 in 1 BOTTLEHistorical
42254-051-904225400519090 in 1 BOTTLEHistorical