OXYCODONE HYDROCHLORIDE

Product NDC
61919-820
11-digit product format
619190820
Labeler code
61919
Product ID
61919-820_98ceed10-20d6-5f7b-e053-2995a90aea72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA203638
Marketing category
ANDA
Marketing start
2019-06-05
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
61919-820-302023-01-30C16284748780-1f386c64a-14a0-0266-e053-dadaa90a7c1aOXYCODONE HYDROCHLORIDE
61919-820-902023-01-30C16284748780-1f386c649-cb6c-0266-e053-dadaa90a7c1aOXYCODONE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-820-30OXYCODONE HYDROCHLORIDE30 in 1 BOTTLETABLET302
61919-820-90OXYCODONE HYDROCHLORIDE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-820-30EA - Each61919-82019f836b3-0701-45b4-8393-a97f73f014e612019-06-19
61919-820-90EA - Each61919-82091ea4c32-61fc-44dc-b38d-93c40defe4d112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-820OXYCODONE HYDROCHLORIDE TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20191204_8a956883-0759-16b8-e053-2a95a90ab1d6.zip
61919-820OXYCODONE HYDROCHLORIDE TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190822_90a1425a-c748-73fd-e053-2a95a90a50b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049611oxyCODONE HCl 15 MG Oral TabletPSN8a956883-0759-16b8-e053-2a95a90ab1d62
1049611oxycodone hydrochloride 15 MG Oral TabletSCD8a956883-0759-16b8-e053-2a95a90ab1d62
1049611oxyCODONE HCl 15 MG Oral TabletPSN90a1425a-c748-73fd-e053-2a95a90a50b51
1049611oxycodone hydrochloride 15 MG Oral TabletSCD90a1425a-c748-73fd-e053-2a95a90a50b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-820-306191908203030 TABLET in 1 BOTTLE (61919-820-30) 30 tablet2019-06-050000-00-00NoNoCurrent
61919-820-906191908209090 TABLET in 1 BOTTLE (61919-820-90) 90 tablet2019-08-210000-00-00NoNoCurrent