FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
71335-0216
11-digit product format
713350216
Labeler code
71335
Product ID
71335-0216_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
2016-03-09
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
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
71335-0216-0Oxycodone and Acetaminophen25 in 1 BOTTLETABLET258
71335-0216-1Oxycodone and Acetaminophen10 in 1 BOTTLETABLET108
71335-0216-2Oxycodone and Acetaminophen120 in 1 BOTTLETABLET1208
71335-0216-3Oxycodone and Acetaminophen28 in 1 BOTTLETABLET288
71335-0216-4Oxycodone and Acetaminophen12 in 1 BOTTLETABLET128
71335-0216-5Oxycodone and Acetaminophen40 in 1 BOTTLETABLET408
71335-0216-6Oxycodone and Acetaminophen30 in 1 BOTTLETABLET308
71335-0216-7Oxycodone and Acetaminophen90 in 1 BOTTLETABLET908
71335-0216-8Oxycodone and Acetaminophen60 in 1 BOTTLETABLET608
71335-0216-9Oxycodone and Acetaminophen84 in 1 BOTTLETABLET848

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0216-6EA - Each71335-0216e22ec2d4-e98a-4502-b07c-e0d5528683c712018-08-13
71335-0216-8EA - Each71335-0216e63cc424-0a13-4502-b6d0-df06c0c3321e12025-09-12

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
71335-0216-07133502160025 TABLET in 1 BOTTLE (71335-0216-0) 25 tablet2016-07-250000-00-00NoNoCurrent
71335-0216-17133502160110 TABLET in 1 BOTTLE (71335-0216-1) 10 tablet2016-07-250000-00-00NoNoCurrent
71335-0216-271335021602120 TABLET in 1 BOTTLE (71335-0216-2) 120 tablet2016-07-250000-00-00NoNoCurrent
71335-0216-37133502160328 TABLET in 1 BOTTLE (71335-0216-3) 28 tablet2016-07-250000-00-00NoNoCurrent
71335-0216-47133502160412 TABLET in 1 BOTTLE (71335-0216-4) 12 tablet2016-07-250000-00-00NoNoCurrent
71335-0216-57133502160540 TABLET in 1 BOTTLE (71335-0216-5) 40 tablet2016-07-250000-00-00NoNoCurrent
71335-0216-67133502160630 TABLET in 1 BOTTLE (71335-0216-6) 30 tablet2016-07-250000-00-00NoNoCurrent
71335-0216-77133502160790 TABLET in 1 BOTTLE (71335-0216-7) 90 tablet2016-07-250000-00-00NoNoCurrent
71335-0216-87133502160860 TABLET in 1 BOTTLE (71335-0216-8) 60 tablet2016-07-250000-00-00NoNoCurrent
71335-0216-97133502160984 TABLET in 1 BOTTLE (71335-0216-9) 84 tablet2016-07-250000-00-00NoNoCurrent