FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
71335-1080
11-digit product format
713351080
Labeler code
71335
Product ID
71335-1080_b195b697-0b1f-4ed8-9ebf-21bb6c0bd552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203638
Marketing category
ANDA
Marketing start
2012-10-30
Substance
OXYCODONE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxycodone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049611

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
71335-1080-12024-05-31C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-22024-05-31C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-32024-05-31C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-42024-05-31C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-52024-05-31C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-62024-05-31C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-72024-05-31C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-82024-05-31C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-92024-05-31C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-12024-01-30C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-22024-01-30C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-32024-01-30C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-42024-01-30C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-52024-01-30C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-62024-01-30C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-72024-01-30C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-82024-01-30C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-1080-92024-01-30C16284748780-11030e365-3e63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1080-1Oxycodone Hydrochloride60 in 1 BOTTLETABLET60101
71335-1080-2Oxycodone Hydrochloride90 in 1 BOTTLETABLET90101
71335-1080-3Oxycodone Hydrochloride30 in 1 BOTTLETABLET30101
71335-1080-4Oxycodone Hydrochloride120 in 1 BOTTLETABLET120101
71335-1080-5Oxycodone Hydrochloride100 in 1 BOTTLETABLET100101
71335-1080-6Oxycodone Hydrochloride56 in 1 BOTTLETABLET56101
71335-1080-7Oxycodone Hydrochloride84 in 1 BOTTLETABLET84101
71335-1080-8Oxycodone Hydrochloride45 in 1 BOTTLETABLET45101
71335-1080-9Oxycodone Hydrochloride18 in 1 BOTTLETABLET18101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1080-3EA - Each71335-10807b6b1f18-ce7b-47e3-a057-bb4af4e0c59412020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1080OXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 9 package rows20240602_d248ceba-9492-4348-aa07-31c9c73a3620.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049611oxyCODONE HCl 15 MG Oral TabletPSNd248ceba-9492-4348-aa07-31c9c73a3620101
1049611oxycodone hydrochloride 15 MG Oral TabletSCDd248ceba-9492-4348-aa07-31c9c73a3620101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1080-17133510800160 TABLET in 1 BOTTLE (71335-1080-1) 60 tablet2019-01-290000-00-00NoNoCurrent
71335-1080-27133510800290 TABLET in 1 BOTTLE (71335-1080-2) 90 tablet2019-01-290000-00-00NoNoCurrent
71335-1080-37133510800330 TABLET in 1 BOTTLE (71335-1080-3) 30 tablet2019-02-150000-00-00NoNoCurrent
71335-1080-471335108004120 TABLET in 1 BOTTLE (71335-1080-4) 120 tablet2019-05-070000-00-00NoNoCurrent
71335-1080-571335108005100 TABLET in 1 BOTTLE (71335-1080-5) 100 tablet2024-05-300000-00-00NoNoCurrent
71335-1080-67133510800656 TABLET in 1 BOTTLE (71335-1080-6) 56 tablet2024-05-300000-00-00NoNoCurrent
71335-1080-77133510800784 TABLET in 1 BOTTLE (71335-1080-7) 84 tablet2024-05-300000-00-00NoNoCurrent
71335-1080-87133510800845 TABLET in 1 BOTTLE (71335-1080-8) 45 tablet2024-05-300000-00-00NoNoCurrent
71335-1080-97133510800918 TABLET in 1 BOTTLE (71335-1080-9) 18 tablet2024-05-300000-00-00NoNoCurrent