FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
71335-1492
11-digit product format
713351492
Labeler code
71335
Product ID
71335-1492_278abe37-2d21-4f39-bb54-f7ccc7cd181a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201278
Marketing category
ANDA
Marketing start
2014-08-28
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxycodone and Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
OXYCODONE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui1049221

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1492-0Oxycodone and Acetaminophen25 in 1 BOTTLETABLET2511
71335-1492-1Oxycodone and Acetaminophen10 in 1 BOTTLETABLET1011
71335-1492-2Oxycodone and Acetaminophen120 in 1 BOTTLETABLET12011
71335-1492-3Oxycodone and Acetaminophen28 in 1 BOTTLETABLET2811
71335-1492-4Oxycodone and Acetaminophen12 in 1 BOTTLETABLET1211
71335-1492-5Oxycodone and Acetaminophen40 in 1 BOTTLETABLET4011
71335-1492-6Oxycodone and Acetaminophen30 in 1 BOTTLETABLET3011
71335-1492-7Oxycodone and Acetaminophen90 in 1 BOTTLETABLET9011
71335-1492-8Oxycodone and Acetaminophen60 in 1 BOTTLETABLET6011
71335-1492-9Oxycodone and Acetaminophen84 in 1 BOTTLETABLET8411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1492-2EA - Each71335-1492e1d26e87-6bd2-41b1-bfff-a06b571cc2ab12024-11-05
71335-1492-5EA - Each71335-14927d9d2841-be5b-49b8-9241-f4f1530982cc12025-02-10
71335-1492-8EA - Each71335-1492628dec9e-981b-4dac-a95e-8875c5fd13ff12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1492OXYCODONE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 10 package rows20240829_fcb09a57-76d8-413c-801b-8d8ea0c3f1db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSNfcb09a57-76d8-413c-801b-8d8ea0c3f1db11
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCDfcb09a57-76d8-413c-801b-8d8ea0c3f1db11
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSYfcb09a57-76d8-413c-801b-8d8ea0c3f1db11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1492-07133514920025 TABLET in 1 BOTTLE (71335-1492-0) 25 tablet2024-04-030000-00-00NoNoCurrent
71335-1492-17133514920110 TABLET in 1 BOTTLE (71335-1492-1) 10 tablet2020-12-110000-00-00NoNoCurrent
71335-1492-271335149202120 TABLET in 1 BOTTLE (71335-1492-2) 120 tablet2020-09-210000-00-00NoNoCurrent
71335-1492-37133514920328 TABLET in 1 BOTTLE (71335-1492-3) 28 tablet2024-04-030000-00-00NoNoCurrent
71335-1492-47133514920412 TABLET in 1 BOTTLE (71335-1492-4) 12 tablet2020-03-090000-00-00NoNoCurrent
71335-1492-57133514920540 TABLET in 1 BOTTLE (71335-1492-5) 40 tablet2020-03-060000-00-00NoNoCurrent
71335-1492-67133514920630 TABLET in 1 BOTTLE (71335-1492-6) 30 tablet2020-01-210000-00-00NoNoCurrent
71335-1492-77133514920790 TABLET in 1 BOTTLE (71335-1492-7) 90 tablet2020-06-110000-00-00NoNoCurrent
71335-1492-87133514920860 TABLET in 1 BOTTLE (71335-1492-8) 60 tablet2020-04-220000-00-00NoNoCurrent
71335-1492-97133514920984 TABLET in 1 BOTTLE (71335-1492-9) 84 tablet2024-04-030000-00-00NoNoCurrent