Tramadol Hydrochloride and Acetaminophen

Product NDC
33358-343
11-digit product format
333580343
Labeler code
33358
Product ID
33358-343_18a40110-4a36-442c-b73e-e3d1fd56837d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RxChange Co.
Application
ANDA090485
Marketing category
ANDA
Marketing start
2014-11-20
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]
DEA schedule
CIV
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-343-30Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET301
33358-343-90Tramadol Hydrochloride and Acetaminophen90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-343-30EA - Each33358-3432a32157a-999c-4d29-aa15-2de6b5b449ca12014-12-01
33358-343-90EA - Each33358-343de33cda2-8af4-438d-9a60-4d569cdcb6d212014-12-01

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-343TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]1Legacy NDC, 2 package rows20141125_c547dd64-5339-4b34-934d-dd7d63989172.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNc547dd64-5339-4b34-934d-dd7d639891721
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDc547dd64-5339-4b34-934d-dd7d639891721
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYc547dd64-5339-4b34-934d-dd7d639891721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-343-303335803433030 in 1 BOTTLEHistorical
33358-343-903335803439090 in 1 BOTTLEHistorical