FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
71335-2049
11-digit product format
713352049
Labeler code
71335
Product ID
71335-2049_0528bfb6-38fa-448e-a709-859515405822
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207510
Marketing category
ANDA
Marketing start
2019-06-01
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

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
71335-2049-1OXYCODONE AND ACETAMINOPHEN30 in 1 BOTTLETABLET30102
71335-2049-2OXYCODONE AND ACETAMINOPHEN120 in 1 BOTTLETABLET120102
71335-2049-3OXYCODONE AND ACETAMINOPHEN90 in 1 BOTTLETABLET90102
71335-2049-4OXYCODONE AND ACETAMINOPHEN28 in 1 BOTTLETABLET28102
71335-2049-5OXYCODONE AND ACETAMINOPHEN60 in 1 BOTTLETABLET60102
71335-2049-6OXYCODONE AND ACETAMINOPHEN20 in 1 BOTTLETABLET20102
71335-2049-7OXYCODONE AND ACETAMINOPHEN45 in 1 BOTTLETABLET45102
71335-2049-8OXYCODONE AND ACETAMINOPHEN75 in 1 BOTTLETABLET75102
71335-2049-9OXYCODONE AND ACETAMINOPHEN100 in 1 BOTTLETABLET100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2049OXYCODONE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 9 package rows20240525_71b1a9be-3231-4b09-a195-d5893104bd4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN71b1a9be-3231-4b09-a195-d5893104bd4a102
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD71b1a9be-3231-4b09-a195-d5893104bd4a102
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY71b1a9be-3231-4b09-a195-d5893104bd4a102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2049-17133520490130 TABLET in 1 BOTTLE (71335-2049-1) 30 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-271335204902120 TABLET in 1 BOTTLE (71335-2049-2) 120 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-37133520490390 TABLET in 1 BOTTLE (71335-2049-3) 90 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-47133520490428 TABLET in 1 BOTTLE (71335-2049-4) 28 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-57133520490560 TABLET in 1 BOTTLE (71335-2049-5) 60 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-67133520490620 TABLET in 1 BOTTLE (71335-2049-6) 20 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-77133520490745 TABLET in 1 BOTTLE (71335-2049-7) 45 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-87133520490875 TABLET in 1 BOTTLE (71335-2049-8) 75 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-971335204909100 TABLET in 1 BOTTLE (71335-2049-9) 100 tablet2022-02-280000-00-00NoNoCurrent