FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
72189-368
11-digit product format
721890368
Labeler code
72189
Product ID
72189-368_3230e687-2f8a-2c27-e063-6294a90a7a1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA207419
Marketing category
ANDA
Marketing start
2022-07-28
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui1049225

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
72189-368-302025-03-27C16284748780-12cef2736-74d6-d83d-e063-dadaa90ab31fOxycodone and Acetaminophen
72189-368-602025-03-27C16284748780-12cef2736-74d6-d83d-e063-dadaa90ab31fOxycodone and Acetaminophen
72189-368-302025-01-30C16284748780-12cef2736-74d6-d83d-e063-dadaa90ab31fOxycodone and Acetaminophen
72189-368-602025-01-30C16284748780-12cef2736-74d6-d83d-e063-dadaa90ab31fOxycodone and Acetaminophen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-368-30Oxycodone and Acetaminophen30 in 1 BOTTLETABLET305
72189-368-60Oxycodone and Acetaminophen60 in 1 BOTTLETABLET605
72189-368-72Oxycodone and Acetaminophen120 in 1 BOTTLETABLET1205
72189-368-90Oxycodone and Acetaminophen90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-368-30EA - Each72189-3685953622f-7c97-46dd-a700-dba1afad172012022-09-12
72189-368-60EA - Each72189-3687eee36f6-df1c-4ad7-9904-c53d773223f412022-09-12
72189-368-90EA - Each72189-3680083ef8b-d8dd-47e3-8362-00810f4bc65612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-368OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT_RX]5Current NDC, Legacy NDC, 4 package rows20250409_e4e27022-581e-ba8c-e053-2a95a90a1ae4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSNe4e27022-581e-ba8c-e053-2a95a90a1ae45
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCDe4e27022-581e-ba8c-e053-2a95a90a1ae45
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSYe4e27022-581e-ba8c-e053-2a95a90a1ae45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-368-307218903683030 TABLET in 1 BOTTLE (72189-368-30) 30 tablet2022-07-280000-00-00NoNoCurrent
72189-368-607218903686060 TABLET in 1 BOTTLE (72189-368-60) 60 tablet2022-07-280000-00-00NoNoCurrent
72189-368-7272189036872120 TABLET in 1 BOTTLE (72189-368-72) 120 tablet2022-07-28NoNoCurrent
72189-368-907218903689090 TABLET in 1 BOTTLE (72189-368-90) 90 tablet2022-07-28NoNoCurrent