FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
13107-043
11-digit product format
131070043
Labeler code
13107
Product ID
13107-043_c86ebd1a-f32c-4a67-9a1b-ff0a3861c124
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA201972
Marketing category
ANDA
Marketing start
2013-07-15
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 2.5 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 HYDROCHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui1049214, 1049221, 1049225, 1049635

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
13107-043-01Oxycodone and Acetaminophen100 in 1 BOTTLETABLET10023
13107-043-05Oxycodone and Acetaminophen500 in 1 BOTTLETABLET50023
13107-043-30Oxycodone and Acetaminophen30 in 1 BOTTLETABLET3023
13107-043-99Oxycodone and Acetaminophen1000 in 1 BOTTLETABLET100023

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-043OXYCODONE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA, LLC]19Current NDC, Legacy NDC, 4 package rows20240707_69df20d9-b1d5-47dc-9ff0-29987284f8c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSN69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049635oxyCODONE HCl 2.5 MG / acetaminophen 325 MG Oral TabletPSN69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049635acetaminophen 325 MG / oxycodone hydrochloride 2.5 MG Oral TabletSCD69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049635APAP 325 MG / Oxycodone Hydrochloride 2.5 MG Oral TabletSY69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY69df20d9-b1d5-47dc-9ff0-29987284f8c723
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY69df20d9-b1d5-47dc-9ff0-29987284f8c723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-043-0113107004301100 TABLET in 1 BOTTLE (13107-043-01) 100 tablet2013-07-150000-00-00NoNoCurrent
13107-043-0513107004305500 TABLET in 1 BOTTLE (13107-043-05) 500 tablet2013-07-150000-00-00NoNoCurrent
13107-043-301310700433030 TABLET in 1 BOTTLE (13107-043-30) 30 tablet2013-07-150000-00-00NoNoCurrent
13107-043-99131070043991000 TABLET in 1 BOTTLE (13107-043-99) 1000 tablet2013-07-150000-00-00NoNoCurrent