FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC
61919-067
11-digit product format
619190067
Labeler code
61919
Product ID
61919-067_5c4871da-3fd7-4b73-8b81-f2f3ddfc248e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA090485
Marketing category
ANDA
Marketing start
2014-01-01
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
61919-067-302020-01-31C16284748780-19d75b9d0-ca30-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
61919-067-602020-01-31C16284748780-19d75b9d0-ca30-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
61919-067-712020-01-31C16284748780-19d75b9d0-ca30-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
61919-067-722020-01-31C16284748780-19d75b9d0-ca30-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-067-30TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN30 in 1 BOTTLETABLET302
61919-067-60TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN60 in 1 BOTTLETABLET602
61919-067-71TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN100 in 1 BOTTLETABLET1002
61919-067-72TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-067-30EA - Each61919-067de8b6de5-e8e6-4377-98dd-c44a71e5d03612015-02-02
61919-067-60EA - Each61919-067f6707522-8570-4094-b8c3-4ea1fb4db9d212015-02-02
61919-067-71EA - Each61919-06798767258-5eb5-42ef-a9f0-18d392dd412e12015-02-02
61919-067-72EA - Each61919-067cdc89459-d980-41c2-ba4b-9d7483f5a09a12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-067TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]2Legacy NDC, 4 package rows20150702_9b600839-6c1b-4000-a9c5-efd74586a68a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN9b600839-6c1b-4000-a9c5-efd74586a68a2
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD9b600839-6c1b-4000-a9c5-efd74586a68a2
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY9b600839-6c1b-4000-a9c5-efd74586a68a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-067-306191900673030 in 1 BOTTLEHistorical
61919-067-606191900676060 in 1 BOTTLEHistorical
61919-067-7161919006771100 in 1 BOTTLEHistorical
61919-067-7261919006772120 in 1 BOTTLEHistorical