FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
61919-612
11-digit product format
619190612
Labeler code
61919
Product ID
61919-612_a7d43073-e0b7-4d37-e053-2a95a90a1486
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Direct rx
Application
ANDA202677
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-612-302025-01-30C16284748780-19d75b9d1-2865-f424-e053-dadaa90a57ceOxycodone and Acetaminophen
61919-612-602025-01-30C16284748780-19d75b9d1-2865-f424-e053-dadaa90a57ceOxycodone and Acetaminophen
61919-612-902025-01-30C16284748780-19d75b9d1-2865-f424-e053-dadaa90a57ceOxycodone and Acetaminophen
61919-612-602020-06-11C16284748780-19d75b9d1-2865-f424-e053-dadaa90a57ceOxycodone and Acetaminophen
61919-612-902020-06-11C16284748780-19d75b9d1-2865-f424-e053-dadaa90a57ceOxycodone and Acetaminophen
61919-612-602020-01-31C16284748780-19d75b9d1-2865-f424-e053-dadaa90a57ceOxycodone and Acetaminophen
61919-612-902020-01-31C16284748780-19d75b9d1-2865-f424-e053-dadaa90a57ceOxycodone and Acetaminophen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-612-30OXYCODONE AND ACETAMINOPHEN30 in 1 BOTTLETABLET306
61919-612-60OXYCODONE AND ACETAMINOPHEN60 in 1 BOTTLETABLET606
61919-612-90OXYCODONE AND ACETAMINOPHEN90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-612-30EA - Each61919-6122ab2a126-684c-49a4-b2f4-fcb90e63ec9412020-07-13
61919-612-60EA - Each61919-6129c87db62-3c6c-4948-acb8-8d545f5e096f12015-04-03
61919-612-90EA - Each61919-6120ee719cd-1c34-4cf7-9040-2d4159b1cea512015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]4
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]4
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-612OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]6Legacy NDC, 3 package rows20230510_ca426616-c243-4582-ab0d-9625a332d9bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNca426616-c243-4582-ab0d-9625a332d9bc6
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDca426616-c243-4582-ab0d-9625a332d9bc6
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYca426616-c243-4582-ab0d-9625a332d9bc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-612-306191906123030 TABLET in 1 BOTTLE (61919-612-30) 30 tablet2015-01-010000-00-00NoNoCurrent
61919-612-606191906126060 TABLET in 1 BOTTLE (61919-612-60) 60 tablet2015-06-010000-00-00NoNoCurrent
61919-612-906191906129090 TABLET in 1 BOTTLE (61919-612-90) 90 tablet2015-06-010000-00-00NoNoCurrent