FDA.reportPublic FDA data

OXYCODONE HYDROCHLORIDE

Product NDC
0115-1560
11-digit product format
001151560
Labeler code
0115
Product ID
0115-1560_335215a2-fcba-4158-bccb-79e026e05467
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
NDA022272
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-02-22
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
OXYCODONE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1860127, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1560-012024-01-30C16284748780-11030e365-1855-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl EXTENDED-RELEASE TABLETS. OXYCODONE HCl EXTENDED-RELEASE TABLETS, for oral use, CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1560-01OXYCODONE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1560-01EA - Each0115-15609e72d48c-a862-457a-b0bf-09a80c66504712016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1560OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]10Current NDC, Legacy NDC, 1 package rows20201230_c2c57ae7-86b9-47bb-a31b-ed1c4327ce7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860157oxyCODONE HCl 10 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860154oxyCODONE HCl 15 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860129oxyCODONE HCl 20 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860151oxyCODONE HCl 30 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860137oxyCODONE HCl 40 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860127oxyCODONE HCl 60 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860148oxyCODONE HCl 80 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSNc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860157Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral TabletSCDc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860154Abuse-Deterrent 12 HR oxycodone hydrochloride 15 MG Extended Release Oral TabletSCDc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860129Abuse-Deterrent 12 HR oxycodone hydrochloride 20 MG Extended Release Oral TabletSCDc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860151Abuse-Deterrent 12 HR oxycodone hydrochloride 30 MG Extended Release Oral TabletSCDc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860137Abuse-Deterrent 12 HR oxycodone hydrochloride 40 MG Extended Release Oral TabletSCDc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860127Abuse-Deterrent 12 HR oxycodone hydrochloride 60 MG Extended Release Oral TabletSCDc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860148Abuse-Deterrent 12 HR oxycodone hydrochloride 80 MG Extended Release Oral TabletSCDc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860157oxycodone HCl 10 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860154oxycodone HCl 15 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860129oxycodone HCl 20 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860151oxycodone HCl 30 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860137oxycodone HCl 40 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860127oxycodone HCl 60 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11
1860148oxycodone HCl 80 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSYc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1560-0100115156001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1560-01) 2016-02-220000-00-00NoNoCurrent