FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
68071-2368
11-digit product format
680712368
Labeler code
68071
Product ID
68071-2368_4b455e52-2501-d55a-e063-6294a90a7ba6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202160
Marketing category
ANDA
Marketing start
2012-07-12
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049621

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
68071-2368-62023-01-30C16284748780-1f386c64a-1e40-0266-e053-dadaa90a7c1aHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. OXYCODONE HYDROCHLORIDE TABLETS, for oral use, CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2368-6Oxycodone Hydrochloride6 in 1 BOTTLETABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2368OXYCODONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 1 package rows20210317_bdade691-3687-3308-e053-2995a90ad6ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049621oxyCODONE HCl 5 MG Oral TabletPSNbdade691-3687-3308-e053-2995a90ad6ed3
1049621oxycodone hydrochloride 5 MG Oral TabletSCDbdade691-3687-3308-e053-2995a90ad6ed3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2368-6680712368066 TABLET in 1 BOTTLE (68071-2368-6) 6 tablet2021-03-160000-00-00NoNoCurrent