FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
52959-119
11-digit product format
529590119
Labeler code
52959
Product ID
52959-119_91b582b6-c0b5-477e-bf84-cb198a6151bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA040778
Marketing category
ANDA
Marketing start
2007-11-27
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
E
Listing certified through
2018-12-31
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
52959-119-022020-01-31C16284748780-19d75b9d0-5029-f424-e053-dadaa90a57ceOxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII
52959-119-202020-01-31C16284748780-19d75b9d0-5029-f424-e053-dadaa90a57ceOxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII
52959-119-302020-01-31C16284748780-19d75b9d0-5029-f424-e053-dadaa90a57ceOxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII
52959-119-602020-01-31C16284748780-19d75b9d0-5029-f424-e053-dadaa90a57ceOxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII
52959-119-902020-01-31C16284748780-19d75b9d0-5029-f424-e053-dadaa90a57ceOxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-119-02Oxycodone and Acetaminophen120 in 1 BOTTLETABLET1202
52959-119-20Oxycodone and Acetaminophen20 in 1 BOTTLETABLET202
52959-119-30Oxycodone and Acetaminophen30 in 1 BOTTLETABLET302
52959-119-60Oxycodone and Acetaminophen60 in 1 BOTTLETABLET602
52959-119-90Oxycodone and Acetaminophen90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-119-02EA - Each52959-119b5882710-43f7-4a20-a4d9-b91977fec43812012-07-24
52959-119-20EA - Each52959-119f28da205-5f83-4113-97bc-d40a1649c29612012-07-24
52959-119-30EA - Each52959-1197301bc7e-05ec-4f44-8f01-96efca34a47912012-07-24
52959-119-60EA - Each52959-11904436a32-4ce7-492c-b115-b080a7c59e5312012-07-24
52959-119-90EA - Each52959-119fea9091b-774e-4db4-982c-f19ee04e91bb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-119OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 5 package rows20110902_a6cce10a-23ba-4eb1-9b1b-0f962f42df81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNa6cce10a-23ba-4eb1-9b1b-0f962f42df812
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDa6cce10a-23ba-4eb1-9b1b-0f962f42df812
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYa6cce10a-23ba-4eb1-9b1b-0f962f42df812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-119-0252959011902120 in 1 BOTTLEHistorical
52959-119-205295901192020 in 1 BOTTLEHistorical
52959-119-305295901193030 in 1 BOTTLEHistorical
52959-119-605295901196060 in 1 BOTTLEHistorical
52959-119-905295901199090 in 1 BOTTLEHistorical