Oxycodone Hydchloride

Product NDC
35356-839
11-digit product format
353560839
Labeler code
35356
Product ID
35356-839_d1220dd0-8ab8-47f6-9da9-e22ea724cda0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydchloride
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA091393
Marketing category
ANDA
Marketing start
2011-12-20
Marketing end
2027-06-30
Substance
OXYCODONE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxycodone Hydchloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049683

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
35356-839-30Oxycodone Hydchloride30 in 1 BOTTLETABLET307
35356-839-60Oxycodone Hydchloride60 in 1 BOTTLETABLET607
35356-839-90Oxycodone Hydchloride90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-839-60EA - Each35356-83972387db3-aa21-4157-b383-3f3007b0146912013-09-04
35356-839-90EA - Each35356-839f90052b4-be6f-4f84-9dd5-6f7034c5617e12013-09-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-839OXYCODONE HYDCHLORIDE TABLET [QUALITY CARE PRODUCTS LLC]7Current NDC, Legacy NDC, 3 package rows20241225_28156b13-0ba9-4dc4-be24-9c3070a7e1cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049683oxyCODONE HCl 10 MG Oral TabletPSN28156b13-0ba9-4dc4-be24-9c3070a7e1cc7
1049683oxycodone hydrochloride 10 MG Oral TabletSCD28156b13-0ba9-4dc4-be24-9c3070a7e1cc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-839-303535608393030 TABLET in 1 BOTTLE (35356-839-30) 30 tablet2011-12-202027-06-30NoNoCurrent
35356-839-603535608396060 TABLET in 1 BOTTLE (35356-839-60) 60 tablet2021-04-302027-06-30NoNoCurrent
35356-839-903535608399090 TABLET in 1 BOTTLE (35356-839-90) 90 tablet2011-12-202027-06-30NoNoCurrent