FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
17856-0920
11-digit product format
178560920
Labeler code
17856
Product ID
17856-0920_bfed68ef-10f3-43dc-a65f-6bf9159b8090
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA204603
Marketing category
ANDA
Marketing start
2018-05-22
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
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
17856-0920-12023-01-30C16284748780-1f386c64a-37f6-0266-e053-dadaa90a7c1aThese 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 (Oxycodone Hydrochloride) SOLUTION for ORAL use. Initial U.S. Approval: 1950
17856-0920-22023-01-30C16284748780-1f386c64a-37f6-0266-e053-dadaa90a7c1aThese 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 (Oxycodone Hydrochloride) SOLUTION for ORAL use. Initial U.S. Approval: 1950
17856-0920-32023-01-30C16284748780-1f386c64a-37f6-0266-e053-dadaa90a7c1aThese 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 (Oxycodone Hydrochloride) SOLUTION for ORAL use. Initial U.S. Approval: 1950
17856-0920-42023-01-30C16284748780-1f386c64a-37f6-0266-e053-dadaa90a7c1aThese 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 (Oxycodone Hydrochloride) SOLUTION for ORAL use. Initial U.S. Approval: 1950
17856-0920-52023-01-30C16284748780-1f386c64a-37f6-0266-e053-dadaa90a7c1aThese 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 (Oxycodone Hydrochloride) SOLUTION for ORAL use. Initial U.S. Approval: 1950
17856-0920-62023-01-30C16284748780-1f386c64a-37f6-0266-e053-dadaa90a7c1aThese 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 (Oxycodone Hydrochloride) SOLUTION for ORAL use. Initial U.S. Approval: 1950
17856-0920-72023-01-30C16284748780-1f386c64a-37f6-0266-e053-dadaa90a7c1aThese 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 (Oxycodone Hydrochloride) SOLUTION for ORAL use. Initial U.S. Approval: 1950
17856-0920-82023-01-30C16284748780-1f386c64a-37f6-0266-e053-dadaa90a7c1aThese 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 (Oxycodone Hydrochloride) SOLUTION for ORAL use. Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0920-1Oxycodone Hydrochloride0.25 mL in 1 SYRINGESOLUTION0.255
17856-0920-2Oxycodone Hydrochloride120 in 1 BOX, UNIT-DOSESOLUTION1205
17856-0920-2Oxycodone Hydrochloride0.125 mL in 1 SYRINGESOLUTION0.1255
17856-0920-3Oxycodone Hydrochloride0.5 mL in 1 SYRINGESOLUTION0.55
17856-0920-3Oxycodone Hydrochloride120 in 1 BOX, UNIT-DOSESOLUTION1205
17856-0920-4Oxycodone Hydrochloride60 in 1 BOX, UNIT-DOSESOLUTION605
17856-0920-4Oxycodone Hydrochloride0.25 mL in 1 SYRINGESOLUTION0.255
17856-0920-5Oxycodone Hydrochloride60 in 1 BOX, UNIT-DOSESOLUTION605
17856-0920-5Oxycodone Hydrochloride0.125 mL in 1 SYRINGESOLUTION0.1255
17856-0920-6Oxycodone Hydrochloride60 in 1 BOX, UNIT-DOSESOLUTION605
17856-0920-6Oxycodone Hydrochloride0.5 mL in 1 SYRINGESOLUTION0.55
17856-0920-7Oxycodone Hydrochloride120 in 1 BOX, UNIT-DOSESOLUTION1205
17856-0920-7Oxycodone Hydrochloride1 mL in 1 SYRINGESOLUTION15
17856-0920-8Oxycodone Hydrochloride60 in 1 BOX, UNIT-DOSESOLUTION605
17856-0920-8Oxycodone Hydrochloride1 mL in 1 SYRINGESOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0920OXYCODONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]5Legacy NDC, 15 package rows20210129_d586b60e-c111-4fc9-ac04-64f3b7d387b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049615oxyCODONE HCl 20 MG in 1 mL Concentrate for Oral SolutionPSNd586b60e-c111-4fc9-ac04-64f3b7d387b85
1049615oxycodone hydrochloride 20 MG/ML Oral SolutionSCDd586b60e-c111-4fc9-ac04-64f3b7d387b85
1049615oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral SolutionSYd586b60e-c111-4fc9-ac04-64f3b7d387b85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0920-117856092001.25 mL in 1 SYRINGE (17856-0920-1) 2021-01-280000-00-00NoNoCurrent
17856-0920-217856092002120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0920-2) > .125 mL in 1 SYRINGE120 syringe2021-01-280000-00-00NoNoCurrent
17856-0920-317856092003120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0920-3) > .5 mL in 1 SYRINGE120 syringe2021-01-280000-00-00NoNoCurrent
17856-0920-41785609200460 SYRINGE in 1 BOX, UNIT-DOSE (17856-0920-4) > .25 mL in 1 SYRINGE60 syringe2021-01-280000-00-00NoNoCurrent
17856-0920-51785609200560 SYRINGE in 1 BOX, UNIT-DOSE (17856-0920-5) > .125 mL in 1 SYRINGE60 syringe2021-01-280000-00-00NoNoCurrent
17856-0920-61785609200660 SYRINGE in 1 BOX, UNIT-DOSE (17856-0920-6) > .5 mL in 1 SYRINGE60 syringe2021-01-280000-00-00NoNoCurrent
17856-0920-717856092007120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0920-7) > 1 mL in 1 SYRINGE120 syringe2021-01-280000-00-00NoNoCurrent
17856-0920-81785609200860 SYRINGE in 1 BOX, UNIT-DOSE (17856-0920-8) > 1 mL in 1 SYRINGE60 syringe2021-01-280000-00-00NoNoCurrent