FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
71335-1742
11-digit product format
713351742
Labeler code
71335
Product ID
71335-1742_c3c5af52-f6d0-43f9-8adf-c046a433c4db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207152
Marketing category
ANDA
Marketing start
2017-03-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol Hydrochloride and Acetaminophen
Listing expiration
2027-12-31

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
71335-1742-1Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET, FILM COATED30105
71335-1742-2Tramadol Hydrochloride and Acetaminophen60 in 1 BOTTLETABLET, FILM COATED60105
71335-1742-3Tramadol Hydrochloride and Acetaminophen90 in 1 BOTTLETABLET, FILM COATED90105
71335-1742-4Tramadol Hydrochloride and Acetaminophen120 in 1 BOTTLETABLET, FILM COATED120105
71335-1742-5Tramadol Hydrochloride and Acetaminophen20 in 1 BOTTLETABLET, FILM COATED20105
71335-1742-6Tramadol Hydrochloride and Acetaminophen40 in 1 BOTTLETABLET, FILM COATED40105
71335-1742-7Tramadol Hydrochloride and Acetaminophen100 in 1 BOTTLETABLET, FILM COATED100105
71335-1742-8Tramadol Hydrochloride and Acetaminophen15 in 1 BOTTLETABLET, FILM COATED15105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1742-2EA - Each71335-1742d80603e8-da30-467a-be84-ad50436cca9012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1742TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 8 package rows20250125_ccf465b5-8ef8-4445-a0d4-23b5cf13188c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNccf465b5-8ef8-4445-a0d4-23b5cf13188c105
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDccf465b5-8ef8-4445-a0d4-23b5cf13188c105
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYccf465b5-8ef8-4445-a0d4-23b5cf13188c105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1742-17133517420130 TABLET, FILM COATED in 1 BOTTLE (71335-1742-1) 2020-12-280000-00-00NoNoCurrent
71335-1742-27133517420260 TABLET, FILM COATED in 1 BOTTLE (71335-1742-2) 2021-01-260000-00-00NoNoCurrent
71335-1742-37133517420390 TABLET, FILM COATED in 1 BOTTLE (71335-1742-3) 2021-03-050000-00-00NoNoCurrent
71335-1742-471335174204120 TABLET, FILM COATED in 1 BOTTLE (71335-1742-4) 2023-03-080000-00-00NoNoCurrent
71335-1742-57133517420520 TABLET, FILM COATED in 1 BOTTLE (71335-1742-5) 2023-05-030000-00-00NoNoCurrent
71335-1742-67133517420640 TABLET, FILM COATED in 1 BOTTLE (71335-1742-6) 2024-04-050000-00-00NoNoCurrent
71335-1742-771335174207100 TABLET, FILM COATED in 1 BOTTLE (71335-1742-7) 2024-04-050000-00-00NoNoCurrent
71335-1742-87133517420815 TABLET, FILM COATED in 1 BOTTLE (71335-1742-8) 2024-04-050000-00-00NoNoCurrent