FDA.reportPublic FDA data

OxyContin

Product NDC
59011-440
11-digit product format
590110440
Labeler code
59011
Product ID
59011-440_4a1edd18-f1f0-4609-9eaf-29067937c3c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Knoa Pharma LLC
Application
NDA022272
Marketing category
NDA
Marketing start
2010-08-08
Substance
OXYCODONE HYDROCHLORIDE
Active strength
40 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
OxyContin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, 1860137, 1860148, 1860151, 1860154, 1860157

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
59011-440-10OxyContin100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10043
59011-440-20OxyContin2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE243
59011-440-20OxyContin10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE1043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59011-440-10EA - Each59011-44066715975-2857-4eca-9a0e-99c09fdd164f12012-07-24
59011-440-20EA - Each59011-4404393cfd5-b3d9-45ec-981b-cb03a86d41bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
OXYCODONEACTIVE MOIETYCD35PMG570OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59011-440OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PURDUE PHARMA LP]39Current NDC, Legacy NDC, 3 package rows20241207_bfdfe235-d717-4855-a3c8-a13d26dadede.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860157oxyCODONE HCl 10 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1860154oxyCODONE HCl 15 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1860129oxyCODONE HCl 20 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1860151oxyCODONE HCl 30 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1860137oxyCODONE HCl 40 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1860127oxyCODONE HCl 60 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1860148oxyCODONE HCl 80 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1049504OxyCONTIN 10 MG 12HR Extended Release Oral TabletPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1049545OxyCONTIN 15 MG 12HR Extended Release Oral TabletPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1049565OxyCONTIN 20 MG 12HR Extended Release Oral TabletPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1049576OxyCONTIN 30 MG 12HR Extended Release Oral TabletPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1049586OxyCONTIN 40 MG 12HR Extended Release Oral TabletPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1049595OxyCONTIN 60 MG 12HR Extended Release Oral TabletPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1049601OxyCONTIN 80 MG 12HR Extended Release Oral TabletPSNbfdfe235-d717-4855-a3c8-a13d26dadede43
1049504Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral Tablet [Oxycontin]SBDbfdfe235-d717-4855-a3c8-a13d26dadede43
1049545Abuse-Deterrent 12 HR oxycodone hydrochloride 15 MG Extended Release Oral Tablet [Oxycontin]SBDbfdfe235-d717-4855-a3c8-a13d26dadede43
1049565Abuse-Deterrent 12 HR oxycodone hydrochloride 20 MG Extended Release Oral Tablet [Oxycontin]SBDbfdfe235-d717-4855-a3c8-a13d26dadede43
1049576Abuse-Deterrent 12 HR oxycodone hydrochloride 30 MG Extended Release Oral Tablet [Oxycontin]SBDbfdfe235-d717-4855-a3c8-a13d26dadede43
1049586Abuse-Deterrent 12 HR oxycodone hydrochloride 40 MG Extended Release Oral Tablet [Oxycontin]SBDbfdfe235-d717-4855-a3c8-a13d26dadede43
1049595Abuse-Deterrent 12 HR oxycodone hydrochloride 60 MG Extended Release Oral Tablet [Oxycontin]SBDbfdfe235-d717-4855-a3c8-a13d26dadede43
1049601Abuse-Deterrent 12 HR oxycodone hydrochloride 80 MG Extended Release Oral Tablet [Oxycontin]SBDbfdfe235-d717-4855-a3c8-a13d26dadede43
1860157Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral TabletSCDbfdfe235-d717-4855-a3c8-a13d26dadede43
1860154Abuse-Deterrent 12 HR oxycodone hydrochloride 15 MG Extended Release Oral TabletSCDbfdfe235-d717-4855-a3c8-a13d26dadede43
1860129Abuse-Deterrent 12 HR oxycodone hydrochloride 20 MG Extended Release Oral TabletSCDbfdfe235-d717-4855-a3c8-a13d26dadede43
1860151Abuse-Deterrent 12 HR oxycodone hydrochloride 30 MG Extended Release Oral TabletSCDbfdfe235-d717-4855-a3c8-a13d26dadede43
1860137Abuse-Deterrent 12 HR oxycodone hydrochloride 40 MG Extended Release Oral TabletSCDbfdfe235-d717-4855-a3c8-a13d26dadede43
1860127Abuse-Deterrent 12 HR oxycodone hydrochloride 60 MG Extended Release Oral TabletSCDbfdfe235-d717-4855-a3c8-a13d26dadede43
1860148Abuse-Deterrent 12 HR oxycodone hydrochloride 80 MG Extended Release Oral TabletSCDbfdfe235-d717-4855-a3c8-a13d26dadede43
104950412 HR Oxycontin 10 MG Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
104954512 HR Oxycontin 15 MG Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
104956512 HR Oxycontin 20 MG Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
104957612 HR Oxycontin 30 MG Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
104958612 HR Oxycontin 40 MG Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
104959512 HR Oxycontin 60 MG Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
104960112 HR Oxycontin 80 MG Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1860157oxycodone HCl 10 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1860154oxycodone HCl 15 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1860129oxycodone HCl 20 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1860151oxycodone HCl 30 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1860137oxycodone HCl 40 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1860127oxycodone HCl 60 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1860148oxycodone HCl 80 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1049504OxyContin 10 MG 12 HR Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1049545OxyContin 15 MG 12 HR Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1049565OxyContin 20 MG 12 HR Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1049576OxyContin 30 MG 12 HR Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1049586OxyContin 40 MG 12 HR Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1049595OxyContin 60 MG 12 HR Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43
1049601OxyContin 80 MG 12 HR Extended Release Oral TabletSYbfdfe235-d717-4855-a3c8-a13d26dadede43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59011-440-1059011044010100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59011-440-10) 2010-08-080000-00-00NoNoCurrent
59011-440-20590110440202 BLISTER PACK in 1 CARTON (59011-440-20) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2010-08-080000-00-00NoNoCurrent