FDA.reportPublic FDA data

oxycodone and acetaminophen

Product NDC
67296-1624
11-digit product format
672961624
Labeler code
67296
Product ID
67296-1624_b8d08a6b-ba8a-74c0-e053-2a95a90a8bf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA090535
Marketing category
ANDA
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
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
67296-1624-12023-01-30C16284748780-1f386c64a-2fb7-0266-e053-dadaa90a7c1aOxy/Apap 5/325
67296-1624-22023-01-30C16284748780-1f386c64a-2fb7-0266-e053-dadaa90a7c1aOxy/Apap 5/325
67296-1624-32023-01-30C16284748780-1f386c64a-2fb7-0266-e053-dadaa90a7c1aOxy/Apap 5/325
67296-1624-52023-01-30C16284748780-1f386c64a-2fb7-0266-e053-dadaa90a7c1aOxy/Apap 5/325
67296-1624-62023-01-30C16284748780-1f386c64a-2fb7-0266-e053-dadaa90a7c1aOxy/Apap 5/325
67296-1624-72023-01-30C16284748780-1f386c64a-2fb7-0266-e053-dadaa90a7c1aOxy/Apap 5/325
67296-1624-82023-01-30C16284748780-1f386c64a-2fb7-0266-e053-dadaa90a7c1aOxy/Apap 5/325
67296-1624-92023-01-30C16284748780-1f386c64a-2fb7-0266-e053-dadaa90a7c1aOxy/Apap 5/325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1624-1oxycodone and acetaminophen10 in 1 BOTTLETABLET102
67296-1624-2oxycodone and acetaminophen20 in 1 BOTTLETABLET202
67296-1624-3oxycodone and acetaminophen30 in 1 BOTTLETABLET302
67296-1624-5oxycodone and acetaminophen50 in 1 BOTTLETABLET502
67296-1624-6oxycodone and acetaminophen6 in 1 BOTTLETABLET62
67296-1624-7oxycodone and acetaminophen15 in 1 BOTTLETABLET152
67296-1624-8oxycodone and acetaminophen12 in 1 BOTTLETABLET122
67296-1624-9oxycodone and acetaminophen60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1624OXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC.]2Legacy NDC, 8 package rows20210114_888bdb1b-4061-09e2-e053-2995a90a2423.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN888bdb1b-4061-09e2-e053-2995a90a24232
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD888bdb1b-4061-09e2-e053-2995a90a24232
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY888bdb1b-4061-09e2-e053-2995a90a24232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1624-16729616240110 TABLET in 1 BOTTLE (67296-1624-1) 10 tablet2019-01-010000-00-00NoNoCurrent
67296-1624-26729616240220 TABLET in 1 BOTTLE (67296-1624-2) 20 tablet2019-01-010000-00-00NoNoCurrent
67296-1624-36729616240330 TABLET in 1 BOTTLE (67296-1624-3) 30 tablet2019-01-010000-00-00NoNoCurrent
67296-1624-56729616240550 TABLET in 1 BOTTLE (67296-1624-5) 50 tablet2019-01-010000-00-00NoNoCurrent
67296-1624-6672961624066 TABLET in 1 BOTTLE (67296-1624-6) 6 tablet2019-01-010000-00-00NoNoCurrent
67296-1624-76729616240715 TABLET in 1 BOTTLE (67296-1624-7) 15 tablet2019-01-010000-00-00NoNoCurrent
67296-1624-86729616240812 TABLET in 1 BOTTLE (67296-1624-8) 12 tablet2019-01-010000-00-00NoNoCurrent
67296-1624-96729616240960 TABLET in 1 BOTTLE (67296-1624-9) 60 tablet2019-01-010000-00-00NoNoCurrent