FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
47781-229
11-digit product format
477810229
Labeler code
47781
Product ID
47781-229_61dc641a-41f6-5a0e-dc3a-8a957328a9c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen, Inc.
Application
ANDA202677
Marketing category
ANDA
Marketing start
2012-01-17
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C, 362O9ITL9D
Rxcui1049214, 1049221, 1049225

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
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b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
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b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
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f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-229-01Oxycodone and Acetaminophen100 in 1 BOTTLETABLET10031
47781-229-05Oxycodone and Acetaminophen500 in 1 BOTTLETABLET50031
47781-229-63Oxycodone and Acetaminophen250 in 1 BOTTLETABLET25031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-229-01EA - Each47781-22974c8848b-b95b-44c4-81af-f90b018a7bab12013-02-13
47781-229-05EA - Each47781-229a2e6c531-604f-431f-92dc-713d1224747d12013-02-13
47781-229-63EA - Each47781-2297ef9f15f-8e65-406d-a86e-a4dda479cb1a12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]8
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-229OXYCODONE AND ACETAMINOPHEN TABLET [ALVOGEN, INC.]28Current NDC, Legacy NDC, 3 package rows20250425_900ec197-720e-5428-b526-055b7756aa4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN900ec197-720e-5428-b526-055b7756aa4a31
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN900ec197-720e-5428-b526-055b7756aa4a31
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSN900ec197-720e-5428-b526-055b7756aa4a31
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD900ec197-720e-5428-b526-055b7756aa4a31
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD900ec197-720e-5428-b526-055b7756aa4a31
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD900ec197-720e-5428-b526-055b7756aa4a31
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY900ec197-720e-5428-b526-055b7756aa4a31
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY900ec197-720e-5428-b526-055b7756aa4a31
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY900ec197-720e-5428-b526-055b7756aa4a31
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN03c9ff0d-46e8-448c-944a-7ad59d1afd6d8
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNb4cf62af-b5d3-4825-9743-9ec3137164e88
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSNb4cf62af-b5d3-4825-9743-9ec3137164e88
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSN03c9ff0d-46e8-448c-944a-7ad59d1afd6d8
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSNb4cf62af-b5d3-4825-9743-9ec3137164e88
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD03c9ff0d-46e8-448c-944a-7ad59d1afd6d8
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDb4cf62af-b5d3-4825-9743-9ec3137164e88
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCDb4cf62af-b5d3-4825-9743-9ec3137164e88
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD03c9ff0d-46e8-448c-944a-7ad59d1afd6d8
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCDb4cf62af-b5d3-4825-9743-9ec3137164e88
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY03c9ff0d-46e8-448c-944a-7ad59d1afd6d8
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYb4cf62af-b5d3-4825-9743-9ec3137164e88
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSYb4cf62af-b5d3-4825-9743-9ec3137164e88
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSYb4cf62af-b5d3-4825-9743-9ec3137164e88
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY03c9ff0d-46e8-448c-944a-7ad59d1afd6d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-229-0147781022901100 TABLET in 1 BOTTLE (47781-229-01) 100 tablet2012-01-170000-00-00NoNoCurrent
47781-229-0547781022905500 TABLET in 1 BOTTLE (47781-229-05) 500 tablet2012-01-170000-00-00NoNoCurrent
47781-229-6347781022963250 in 1 BOTTLEHistorical