FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC
42571-119
11-digit product format
425710119
Labeler code
42571
Product ID
42571-119_46978b2e-ad09-e4f1-e063-6394a90a5208
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA201952
Marketing category
ANDA
Marketing start
2012-12-15
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
42571-119-01TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN100 in 1 BOTTLETABLET, FILM COATED10028
42571-119-05TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN500 in 1 BOTTLETABLET, FILM COATED50028
42571-119-23TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN8 in 1 CARTONTABLET, FILM COATED828
42571-119-32TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN10 in 1 BLISTER PACKTABLET, FILM COATED1028
42571-119-90TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN90 in 1 BOTTLETABLET, FILM COATED9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-119-01EA - Each42571-119ca1cbd33-5f32-41c4-bab7-ead0ef80c66312013-07-02
42571-119-05EA - Each42571-119fd47a9a1-7410-425d-a3ef-442d09d7f58c12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-119TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, FILM COATED [MICRO LABS LIMITED]27Current NDC, Legacy NDC, 5 package rows20231228_ab84058e-e52c-4b81-badc-4b0c26aab259.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNab84058e-e52c-4b81-badc-4b0c26aab25928
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDab84058e-e52c-4b81-badc-4b0c26aab25928
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYab84058e-e52c-4b81-badc-4b0c26aab25928
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN82d8b70f-aebf-4b9a-89b1-183fc9e2ff591
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD82d8b70f-aebf-4b9a-89b1-183fc9e2ff591
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY82d8b70f-aebf-4b9a-89b1-183fc9e2ff591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-119-0142571011901100 TABLET, FILM COATED in 1 BOTTLE (42571-119-01) 2012-12-150000-00-00NoNoCurrent
42571-119-0542571011905500 TABLET, FILM COATED in 1 BOTTLE (42571-119-05) 2012-12-150000-00-00NoNoCurrent
42571-119-23425710119238 BLISTER PACK in 1 CARTON (42571-119-23) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-119-32) 8 blister pack2012-12-150000-00-00NoNoCurrent
42571-119-324257101193210 in 1 BLISTER PACKHistorical
42571-119-904257101199090 TABLET, FILM COATED in 1 BOTTLE (42571-119-90) 2012-12-150000-00-00NoNoCurrent