FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
68788-0985
11-digit product format
687880985
Labeler code
68788
Product ID
68788-0985_36418db0-63c5-4431-8e99-19f2f3c406c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
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
68788-0985-12020-01-31C16284748780-19d75b9d0-2041-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP CIV
68788-0985-22020-01-31C16284748780-19d75b9d0-2041-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP CIV
68788-0985-32020-01-31C16284748780-19d75b9d0-2041-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP CIV
68788-0985-42020-01-31C16284748780-19d75b9d0-2041-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP CIV
68788-0985-52020-01-31C16284748780-19d75b9d0-2041-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP CIV
68788-0985-62020-01-31C16284748780-19d75b9d0-2041-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP CIV
68788-0985-82020-01-31C16284748780-19d75b9d0-2041-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP CIV
68788-0985-92020-01-31C16284748780-19d75b9d0-2041-f424-e053-dadaa90a57ceTramadol Hydrochloride and Acetaminophen Tablets, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-0985-1Tramadol Hydrochloride and Acetaminophen100 in 1 BOTTLE, DISPENSINGTABLET1009
68788-0985-2Tramadol Hydrochloride and Acetaminophen20 in 1 BOTTLE, DISPENSINGTABLET209
68788-0985-3Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLE, DISPENSINGTABLET309
68788-0985-4Tramadol Hydrochloride and Acetaminophen40 in 1 BOTTLE, DISPENSINGTABLET409
68788-0985-5Tramadol Hydrochloride and Acetaminophen50 in 1 BOTTLE, DISPENSINGTABLET509
68788-0985-6Tramadol Hydrochloride and Acetaminophen60 in 1 BOTTLE, DISPENSINGTABLET609
68788-0985-8Tramadol Hydrochloride and Acetaminophen120 in 1 BOTTLE, DISPENSINGTABLET1209
68788-0985-9Tramadol Hydrochloride and Acetaminophen90 in 1 BOTTLE, DISPENSINGTABLET909

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-0985TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]9Legacy NDC, 8 package rows20160920_8a6e1be7-35af-4cab-99d9-4360ff48bf06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN8a6e1be7-35af-4cab-99d9-4360ff48bf069
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD8a6e1be7-35af-4cab-99d9-4360ff48bf069
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY8a6e1be7-35af-4cab-99d9-4360ff48bf069

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-0985-168788098501100 in 1 BOTTLE, DISPENSINGHistorical
68788-0985-26878809850220 in 1 BOTTLE, DISPENSINGHistorical
68788-0985-36878809850330 in 1 BOTTLE, DISPENSINGHistorical
68788-0985-46878809850440 in 1 BOTTLE, DISPENSINGHistorical
68788-0985-56878809850550 in 1 BOTTLE, DISPENSINGHistorical
68788-0985-66878809850660 in 1 BOTTLE, DISPENSINGHistorical
68788-0985-868788098508120 in 1 BOTTLE, DISPENSINGHistorical
68788-0985-96878809850990 in 1 BOTTLE, DISPENSINGHistorical