FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
71335-0111
11-digit product format
713350111
Labeler code
71335
Product ID
71335-0111_1c50d830-dc13-481d-b224-0260a6447d12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090485
Marketing category
ANDA
Marketing start
2009-12-17
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
71335-0111-1Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET309
71335-0111-2Tramadol Hydrochloride and Acetaminophen60 in 1 BOTTLETABLET609
71335-0111-3Tramadol Hydrochloride and Acetaminophen90 in 1 BOTTLETABLET909
71335-0111-4Tramadol Hydrochloride and Acetaminophen120 in 1 BOTTLETABLET1209
71335-0111-5Tramadol Hydrochloride and Acetaminophen20 in 1 BOTTLETABLET209
71335-0111-6Tramadol Hydrochloride and Acetaminophen40 in 1 BOTTLETABLET409
71335-0111-7Tramadol Hydrochloride and Acetaminophen100 in 1 BOTTLETABLET1009
71335-0111-8Tramadol Hydrochloride and Acetaminophen15 in 1 BOTTLETABLET159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0111-1EA - Each71335-0111fdb57bd8-0e9a-44e1-90fe-2ea469b740d912018-03-08
71335-0111-2EA - Each71335-0111dcee3500-ead3-42ca-a666-c5b3a9149f3612018-03-08
71335-0111-3EA - Each71335-011147265065-0b0c-4b97-bc92-d71d3526ac8512018-03-08
71335-0111-4EA - Each71335-0111af9b106e-f6ad-4023-b504-86cc9a6fbd8412018-03-08
71335-0111-5EA - Each71335-0111bcf7be74-e0a4-434e-93dd-f20b831749ed12018-03-08
71335-0111-6EA - Each71335-01116a7718c4-e277-42d5-bc52-fceeb463a94012018-03-08
71335-0111-7EA - Each71335-01112bd90204-c16f-4d96-9764-d4d4bd626a3812018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0111TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 8 package rows20240901_f33fcd05-2c95-48dd-884b-5ed9c25c2ccf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNf33fcd05-2c95-48dd-884b-5ed9c25c2ccf9
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDf33fcd05-2c95-48dd-884b-5ed9c25c2ccf9
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYf33fcd05-2c95-48dd-884b-5ed9c25c2ccf9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0111-17133501110130 TABLET in 1 BOTTLE (71335-0111-1) 30 tablet2021-03-170000-00-00NoNoCurrent
71335-0111-27133501110260 TABLET in 1 BOTTLE (71335-0111-2) 60 tablet2021-04-140000-00-00NoNoCurrent
71335-0111-37133501110390 TABLET in 1 BOTTLE (71335-0111-3) 90 tablet2021-08-200000-00-00NoNoCurrent
71335-0111-471335011104120 TABLET in 1 BOTTLE (71335-0111-4) 120 tablet2022-09-260000-00-00NoNoCurrent
71335-0111-57133501110520 TABLET in 1 BOTTLE (71335-0111-5) 20 tablet2021-04-140000-00-00NoNoCurrent
71335-0111-67133501110640 TABLET in 1 BOTTLE (71335-0111-6) 40 tablet2022-09-260000-00-00NoNoCurrent
71335-0111-771335011107100 TABLET in 1 BOTTLE (71335-0111-7) 100 tablet2022-09-260000-00-00NoNoCurrent
71335-0111-87133501110815 TABLET in 1 BOTTLE (71335-0111-8) 15 tablet2022-09-260000-00-00NoNoCurrent