FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
61919-871
11-digit product format
619190871
Labeler code
61919
Product ID
61919-871_3a85db26-4c30-c5dc-e063-6294a90ac2a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA207419
Marketing category
ANDA
Marketing start
2019-08-21
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
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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui1049214

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
61919-871-602025-05-08C16284748780-12cef2736-6e83-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN
61919-871-302025-01-30C16284748780-12cef2736-b0b4-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN
61919-871-602025-01-30C16284748780-12cef2736-6e83-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN
61919-871-902025-01-30C16284748780-12cef2736-6eba-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-871-60OXYCODONE AND ACETAMINOPHEN60 in 1 BOTTLETABLET606
61919-871-72OXYCODONE AND ACETAMINOPHEN120 in 1 BOTTLETABLET1206
61919-871-30OXYCODONE AND ACETAMINOPHEN30 in 1 BOTTLETABLET302
61919-871-90OXYCODONE AND ACETAMINOPHEN90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-871-30EA - Each61919-87139be9529-b5ee-40c3-8806-fd8686f1321e12019-09-05
61919-871-60EA - Each61919-871cb0850f6-bf99-4a95-adae-894438dfb9b112019-09-05
61919-871-72EA - Each61919-871667e98f2-a5dd-4bab-ac23-6b62fc05b8e912025-08-11
61919-871-90EA - Each61919-871f4250700-c8da-408a-ab53-ecd4d71c8fd412019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-871OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT_RX]3Current NDC, Legacy NDC, 2 package rows20250509_90a11364-fc42-e94e-e053-2a95a90a9782.zip
61919-871OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20230113_90a0f138-3afa-1fb6-e053-2995a90a96fe.zip
61919-871OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20230113_90a0ede7-6c30-1b33-e053-2995a90a2cf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN90a11364-fc42-e94e-e053-2a95a90a97826
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD90a11364-fc42-e94e-e053-2a95a90a97826
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY90a11364-fc42-e94e-e053-2a95a90a97826
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN90a0ede7-6c30-1b33-e053-2995a90a2cf82
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN90a0f138-3afa-1fb6-e053-2995a90a96fe2
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD90a0ede7-6c30-1b33-e053-2995a90a2cf82
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD90a0f138-3afa-1fb6-e053-2995a90a96fe2
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY90a0ede7-6c30-1b33-e053-2995a90a2cf82
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY90a0f138-3afa-1fb6-e053-2995a90a96fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-871-306191908713030 TABLET in 1 BOTTLE (61919-871-30) 30 tablet2019-08-210000-00-00NoNoCurrent
61919-871-606191908716060 TABLET in 1 BOTTLE (61919-871-60) 60 tablet2019-08-210000-00-00NoNoCurrent
61919-871-7261919087172120 TABLET in 1 BOTTLE (61919-871-72) 120 tablet2019-08-21NoNoHistorical
61919-871-906191908719090 TABLET in 1 BOTTLE (61919-871-90) 90 tablet2019-08-210000-00-00NoNoCurrent