FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
72189-257
11-digit product format
721890257
Labeler code
72189
Product ID
72189-257_eac6d5fd-c378-01d6-e053-2995a90a9650
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
DirectRx
Application
ANDA207510
Marketing category
ANDA
Marketing start
2021-08-24
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-257-302025-01-30C16284748780-12cef2736-621f-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN
72189-257-602025-01-30C16284748780-12cef2736-621f-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN
72189-257-902025-01-30C16284748780-12cef2736-621f-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-257-30OXYCODONE AND ACETAMINOPHEN30 in 1 BOTTLETABLET303
72189-257-60OXYCODONE AND ACETAMINOPHEN60 in 1 BOTTLETABLET603
72189-257-90OXYCODONE AND ACETAMINOPHEN90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-257OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX]3Legacy NDC, 3 package rows20230707_ca4e7762-1f34-6b11-e053-2a95a90ace8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSNca4e7762-1f34-6b11-e053-2a95a90ace8c3
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCDca4e7762-1f34-6b11-e053-2a95a90ace8c3
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSYca4e7762-1f34-6b11-e053-2a95a90ace8c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-257-307218902573030 TABLET in 1 BOTTLE (72189-257-30) 30 tablet2021-08-240000-00-00NoNoCurrent
72189-257-607218902576060 TABLET in 1 BOTTLE (72189-257-60) 60 tablet2021-08-240000-00-00NoNoCurrent
72189-257-907218902579090 TABLET in 1 BOTTLE (72189-257-90) 90 tablet2021-08-240000-00-00NoNoCurrent