Oxycodone

Product NDC
67877-623
11-digit product format
678770623
Labeler code
67877
Product ID
67877-623_0f91e433-a264-468a-8600-0a1986e69977
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone
Dosage form
SOLUTION
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA211748
Marketing category
ANDA
Marketing start
2019-02-09
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product 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
67877-623-192024-07-30C16284748780-1e4f33bdf-ab7b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950
67877-623-882024-07-30C16284748780-1e4f33bdf-ab7b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950
67877-623-912024-07-30C16284748780-1e4f33bdf-ab7b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950
67877-623-192022-09-21C16284748780-1e4f33bdf-ab7b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950
67877-623-882022-09-21C16284748780-1e4f33bdf-ab7b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950
67877-623-912022-09-21C16284748780-1e4f33bdf-ab7b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950
67877-623-192022-07-29C16284748780-1e4f33bdf-ab7b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950
67877-623-882022-07-29C16284748780-1e4f33bdf-ab7b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950
67877-623-912022-07-29C16284748780-1e4f33bdf-ab7b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-623-19Oxycodone15 mL in 1 BOTTLE, PLASTICSOLUTION156
67877-623-88Oxycodone100 mL in 1 BOTTLE, PLASTICSOLUTION1006
67877-623-91Oxycodone500 mL in 1 BOTTLE, PLASTICSOLUTION5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-623OXYCODONE SOLUTION [ASCEND LABORATORIES, LLC]6Legacy NDC, 3 package rows20220922_08b29d8d-6145-494d-bfa0-c493179f5b5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049604oxyCODONE HCl 5 MG in 5 mL Oral SolutionPSN08b29d8d-6145-494d-bfa0-c493179f5b5e6
1049604oxycodone hydrochloride 1 MG/ML Oral SolutionSCD08b29d8d-6145-494d-bfa0-c493179f5b5e6
1049604oxycodone hydrochloride 5 MG per 5 ML Oral SolutionSY08b29d8d-6145-494d-bfa0-c493179f5b5e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-623-196787706231915 mL in 1 BOTTLE, PLASTIC (67877-623-19) 15 ml2019-02-090000-00-00NoNoCurrent
67877-623-8867877062388100 mL in 1 BOTTLE, PLASTIC (67877-623-88) 100 ml2019-02-090000-00-00NoNoCurrent
67877-623-9167877062391500 mL in 1 BOTTLE, PLASTIC (67877-623-91) 500 ml2019-02-090000-00-00NoNoCurrent