FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
71335-0146
11-digit product format
713350146
Labeler code
71335
Product ID
71335-0146_68226f26-8369-4b58-a0e9-e9b943a8df09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202677
Marketing category
ANDA
Marketing start
2012-01-17
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui1049214, 1049221, 1049225

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
71335-0146-0Oxycodone and Acetaminophen112 in 1 BOTTLETABLET1128
71335-0146-1Oxycodone and Acetaminophen30 in 1 BOTTLETABLET308
71335-0146-2Oxycodone and Acetaminophen120 in 1 BOTTLETABLET1208
71335-0146-3Oxycodone and Acetaminophen90 in 1 BOTTLETABLET908
71335-0146-4Oxycodone and Acetaminophen28 in 1 BOTTLETABLET288
71335-0146-5Oxycodone and Acetaminophen60 in 1 BOTTLETABLET608
71335-0146-6Oxycodone and Acetaminophen20 in 1 BOTTLETABLET208
71335-0146-7Oxycodone and Acetaminophen45 in 1 BOTTLETABLET458
71335-0146-8Oxycodone and Acetaminophen75 in 1 BOTTLETABLET758
71335-0146-9Oxycodone and Acetaminophen100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0146-1EA - Each71335-0146fef639a2-c360-4b52-b9f8-3d9e9579c57812018-05-09
71335-0146-3EA - Each71335-01460928c5bf-16d0-4638-a3d4-04f5fb169fe312018-04-19
71335-0146-5EA - Each71335-0146bedc4149-bc1d-4708-99c0-508c9e56139412018-04-19

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNb4cf62af-b5d3-4825-9743-9ec3137164e88
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSNb4cf62af-b5d3-4825-9743-9ec3137164e88
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSNb4cf62af-b5d3-4825-9743-9ec3137164e88
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDb4cf62af-b5d3-4825-9743-9ec3137164e88
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCDb4cf62af-b5d3-4825-9743-9ec3137164e88
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCDb4cf62af-b5d3-4825-9743-9ec3137164e88
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYb4cf62af-b5d3-4825-9743-9ec3137164e88
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSYb4cf62af-b5d3-4825-9743-9ec3137164e88
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSYb4cf62af-b5d3-4825-9743-9ec3137164e88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0146-071335014600112 TABLET in 1 BOTTLE (71335-0146-0) 112 tablet2012-01-170000-00-00NoNoCurrent
71335-0146-17133501460130 TABLET in 1 BOTTLE (71335-0146-1) 30 tablet2012-01-170000-00-00NoNoCurrent
71335-0146-271335014602120 TABLET in 1 BOTTLE (71335-0146-2) 120 tablet2012-01-170000-00-00NoNoCurrent
71335-0146-37133501460390 TABLET in 1 BOTTLE (71335-0146-3) 90 tablet2012-01-170000-00-00NoNoCurrent
71335-0146-47133501460428 TABLET in 1 BOTTLE (71335-0146-4) 28 tablet2012-01-170000-00-00NoNoCurrent
71335-0146-57133501460560 TABLET in 1 BOTTLE (71335-0146-5) 60 tablet2012-01-170000-00-00NoNoCurrent
71335-0146-67133501460620 TABLET in 1 BOTTLE (71335-0146-6) 20 tablet2012-01-170000-00-00NoNoCurrent
71335-0146-77133501460745 TABLET in 1 BOTTLE (71335-0146-7) 45 tablet2012-01-170000-00-00NoNoCurrent
71335-0146-87133501460875 TABLET in 1 BOTTLE (71335-0146-8) 75 tablet2012-01-170000-00-00NoNoCurrent
71335-0146-971335014609100 TABLET in 1 BOTTLE (71335-0146-9) 100 tablet2012-01-170000-00-00NoNoCurrent