FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
50268-646
11-digit product format
502680646
Labeler code
50268
Product ID
50268-646_48ec761b-a7bc-59ef-e063-6294a90a579b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA040778
Marketing category
ANDA
Marketing start
2018-07-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxycodone and Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
OXYCODONE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui1049214, 1049221, 1049225

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
50268-646-11Oxycodone and Acetaminophen1 in 1 BLISTER PACKTABLET19
50268-646-15Oxycodone and Acetaminophen50 in 1 BOXTABLET509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-646-11EA - Each50268-6465e3d8267-f335-4a5d-8304-b25a212a248b12018-09-05
50268-646-15EA - Each50268-646d14201b6-c3e2-4230-af1b-796435f7f7ea12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-646OXYCODONE AND ACETAMINOPHEN TABLET [AVPAK]7Current NDC, Legacy NDC, 2 package rows20240110_7055acd5-1cbb-397e-e053-2a91aa0a3852.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN7055acd5-1cbb-397e-e053-2a91aa0a38529
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN7055acd5-1cbb-397e-e053-2a91aa0a38529
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSN7055acd5-1cbb-397e-e053-2a91aa0a38529
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD7055acd5-1cbb-397e-e053-2a91aa0a38529
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD7055acd5-1cbb-397e-e053-2a91aa0a38529
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD7055acd5-1cbb-397e-e053-2a91aa0a38529
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY7055acd5-1cbb-397e-e053-2a91aa0a38529
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY7055acd5-1cbb-397e-e053-2a91aa0a38529
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY7055acd5-1cbb-397e-e053-2a91aa0a38529

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-646-11502680646111 in 1 BLISTER PACKHistorical
50268-646-155026806461550 BLISTER PACK in 1 BOX (50268-646-15) / 1 TABLET in 1 BLISTER PACK (50268-646-11) 50 blister pack2018-07-090000-00-00NoNoCurrent