FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
66336-147
11-digit product format
663360147
Labeler code
66336
Product ID
66336-147_9c4d3166-fb57-445e-b13e-1d19a0a5b0cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA040545
Marketing category
ANDA
Marketing start
2011-03-08
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
2017-12-31
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
66336-147-242019-11-13C16284748780-197449f38-cb4b-f6ea-e053-dbdaa90aa703OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only
66336-147-302019-11-13C16284748780-197449f38-cb4b-f6ea-e053-dbdaa90aa703OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only
66336-147-552019-11-13C16284748780-197449f38-cb4b-f6ea-e053-dbdaa90aa703OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only
66336-147-602019-11-13C16284748780-197449f38-cb4b-f6ea-e053-dbdaa90aa703OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only
66336-147-902019-11-13C16284748780-197449f38-cb4b-f6ea-e053-dbdaa90aa703OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only
66336-147-942019-11-13C16284748780-197449f38-cb4b-f6ea-e053-dbdaa90aa703OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-147-24OXYCODONE AND ACETAMINOPHEN24 in 1 BOTTLETABLET241
66336-147-30OXYCODONE AND ACETAMINOPHEN30 in 1 BOTTLETABLET301
66336-147-55OXYCODONE AND ACETAMINOPHEN150 in 1 BOTTLETABLET1501
66336-147-60OXYCODONE AND ACETAMINOPHEN60 in 1 BOTTLETABLET601
66336-147-90OXYCODONE AND ACETAMINOPHEN90 in 1 BOTTLETABLET901
66336-147-94OXYCODONE AND ACETAMINOPHEN120 in 1 BOTTLETABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-147-60EA - Each66336-1470edc1a4e-e5f0-44f2-872e-b80c96575dbb12012-07-24
66336-147-90EA - Each66336-1470fe039f0-258c-4cd5-9173-275c1a9b9dca12012-07-24
66336-147-94EA - Each66336-147eb6dc662-cbe6-48fe-a135-61fe29163a0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-147OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 6 package rows20111007_77a4aae7-a0cc-4f86-b91f-ec4112c6d3be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN77a4aae7-a0cc-4f86-b91f-ec4112c6d3be1
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD77a4aae7-a0cc-4f86-b91f-ec4112c6d3be1
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY77a4aae7-a0cc-4f86-b91f-ec4112c6d3be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-147-246633601472424 in 1 BOTTLEHistorical
66336-147-306633601473030 in 1 BOTTLEHistorical
66336-147-5566336014755150 in 1 BOTTLEHistorical
66336-147-606633601476060 in 1 BOTTLEHistorical
66336-147-906633601479090 in 1 BOTTLEHistorical
66336-147-9466336014794120 in 1 BOTTLEHistorical