FDA.reportPublic FDA data

OXYCODONE HYDROCHLORIDE

Product NDC
0121-0827
11-digit product format
001210827
Labeler code
0121
Product ID
0121-0827_1685138a-dd0b-4e6e-b14d-a1132eef8b34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA206914
Marketing category
ANDA
Marketing start
2019-04-08
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OXYCODONE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049604

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
0121-0827-04OXYCODONE HYDROCHLORIDE118 mL in 1 BOTTLESOLUTION11814
0121-0827-16OXYCODONE HYDROCHLORIDE500 mL in 1 BOTTLESOLUTION50014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0827OXYCODONE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]13Current NDC, Legacy NDC, 2 package rows20240704_73b063b5-24b7-40bf-bc2a-c0e1bfaf61d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049604oxyCODONE HCl 5 MG in 5 mL Oral SolutionPSN73b063b5-24b7-40bf-bc2a-c0e1bfaf61d114
1049604oxycodone hydrochloride 1 MG/ML Oral SolutionSCD73b063b5-24b7-40bf-bc2a-c0e1bfaf61d114
1049604oxycodone hydrochloride 5 MG per 5 ML Oral SolutionSY73b063b5-24b7-40bf-bc2a-c0e1bfaf61d114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0827-0400121082704118 mL in 1 BOTTLE (0121-0827-04) 118 ml2019-04-080000-00-00NoNoCurrent
0121-0827-1600121082716500 mL in 1 BOTTLE (0121-0827-16) 500 ml2019-04-080000-00-00NoNoCurrent