FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
63187-824
11-digit product format
631870824
Labeler code
63187
Product ID
63187-824_9f711da8-c5d3-42ae-a8bc-bfdc75b1baf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201278
Marketing category
ANDA
Marketing start
2014-08-28
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
Rxcui1049221

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
63187-824-10Oxycodone and Acetaminophen10 in 1 BOTTLE, PLASTICTABLET105
63187-824-12Oxycodone and Acetaminophen12 in 1 BOTTLE, PLASTICTABLET125
63187-824-15Oxycodone and Acetaminophen15 in 1 BOTTLE, PLASTICTABLET155
63187-824-20Oxycodone and Acetaminophen20 in 1 BOTTLE, PLASTICTABLET205
63187-824-30Oxycodone and Acetaminophen30 in 1 BOTTLE, PLASTICTABLET305
63187-824-60Oxycodone and Acetaminophen60 in 1 BOTTLE, PLASTICTABLET605
63187-824-90Oxycodone and Acetaminophen90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-824-10EA - Each63187-824dd9ca5a5-ca5a-4ec7-8c75-2394d01cb08d12018-02-20
63187-824-30EA - Each63187-824cd8c51c0-6eaf-4d66-b04d-a37574b243f412017-06-15
63187-824-60EA - Each63187-824a616e9aa-9a96-41f2-a105-0df8a08ef7a712017-07-07
63187-824-90EA - Each63187-8246c992e29-c642-482c-9b3f-05ca16043fd112017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-824OXYCODONE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 7 package rows20221102_ad03068c-1af4-46ce-bdea-c2745b1c1e52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSNad03068c-1af4-46ce-bdea-c2745b1c1e525
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCDad03068c-1af4-46ce-bdea-c2745b1c1e525
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSYad03068c-1af4-46ce-bdea-c2745b1c1e525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-824-106318708241010 TABLET in 1 BOTTLE, PLASTIC (63187-824-10) 10 tablet2017-12-010000-00-00NoNoCurrent
63187-824-126318708241212 TABLET in 1 BOTTLE, PLASTIC (63187-824-12) 12 tablet2017-03-010000-00-00NoNoCurrent
63187-824-156318708241515 TABLET in 1 BOTTLE, PLASTIC (63187-824-15) 15 tablet2014-08-280000-00-00NoNoCurrent
63187-824-206318708242020 TABLET in 1 BOTTLE, PLASTIC (63187-824-20) 20 tablet2014-08-280000-00-00NoNoCurrent
63187-824-306318708243030 TABLET in 1 BOTTLE, PLASTIC (63187-824-30) 30 tablet2017-03-010000-00-00NoNoCurrent
63187-824-606318708246060 TABLET in 1 BOTTLE, PLASTIC (63187-824-60) 60 tablet2017-03-010000-00-00NoNoCurrent
63187-824-906318708249090 TABLET in 1 BOTTLE, PLASTIC (63187-824-90) 90 tablet2017-03-010000-00-00NoNoCurrent