Oxycodone

Product NDC
67877-625
11-digit product format
678770625
Labeler code
67877
Product ID
67877-625_e8a3f868-73de-4bf7-b04b-df4ea9c0d533
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone
Dosage form
SOLUTION
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA211749
Marketing category
ANDA
Marketing start
2019-02-06
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
100 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
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
67877-625-192024-07-30C16284748780-1e4f33bdf-a713-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
67877-625-592024-07-30C16284748780-1e4f33bdf-a713-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
67877-625-192022-09-22C16284748780-1e4f33bdf-a713-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
67877-625-592022-09-22C16284748780-1e4f33bdf-a713-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
67877-625-192022-07-29C16284748780-1e4f33bdf-a713-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
67877-625-592022-07-29C16284748780-1e4f33bdf-a713-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
67877-625-19Oxycodone15 mL in 1 BOTTLE, PLASTICSOLUTION157
67877-625-19Oxycodone1 in 1 CARTONSOLUTION17
67877-625-59Oxycodone30 in 1 CARTONSOLUTION307
67877-625-59Oxycodone30 mL in 1 BOTTLE, PLASTICSOLUTION307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-625OXYCODONE SOLUTION [ASCEND LABORATORIES, LLC]7Legacy NDC, 4 package rows20220923_cc09aa92-98fc-4a01-a901-03903a97f46e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049615oxyCODONE HCl 20 MG in 1 mL Concentrate for Oral SolutionPSNcc09aa92-98fc-4a01-a901-03903a97f46e7
1049615oxycodone hydrochloride 20 MG/ML Oral SolutionSCDcc09aa92-98fc-4a01-a901-03903a97f46e7
1049615oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral SolutionSYcc09aa92-98fc-4a01-a901-03903a97f46e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-625-19678770625191 BOTTLE, PLASTIC in 1 CARTON (67877-625-19) > 15 mL in 1 BOTTLE, PLASTIC2019-02-060000-00-00NoNoCurrent
67877-625-596787706255930 BOTTLE, PLASTIC in 1 CARTON (67877-625-59) > 30 mL in 1 BOTTLE, PLASTIC2019-02-060000-00-00NoNoCurrent