FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
40032-950
11-digit product format
400320950
Labeler code
40032
Product ID
40032-950_65077bf1-49cf-4205-91f6-d6e2e81281ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA204752
Marketing category
ANDA
Marketing start
2015-08-24
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxycodone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049696

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
40032-950-012023-12-13C16284748780-19d75b9d0-4d26-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsule for ORAL use, CII Initial U.S. Approval: 1950
40032-950-032023-12-13C16284748780-19d75b9d0-4d26-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsule for ORAL use, CII Initial U.S. Approval: 1950
40032-950-502023-12-13C16284748780-19d75b9d0-4d26-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsule for ORAL use, CII Initial U.S. Approval: 1950
40032-950-012020-01-31C16284748780-19d75b9d0-4d26-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsule for ORAL use, CII Initial U.S. Approval: 1950
40032-950-032020-01-31C16284748780-19d75b9d0-4d26-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsule for ORAL use, CII Initial U.S. Approval: 1950
40032-950-502020-01-31C16284748780-19d75b9d0-4d26-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsule for ORAL use, CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-950-01Oxycodone Hydrochloride100 in 1 BOTTLECAPSULE1007
40032-950-03Oxycodone Hydrochloride30 in 1 BOTTLECAPSULE307
40032-950-50Oxycodone Hydrochloride500 in 1 BOTTLECAPSULE5007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-950OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]7Current NDC, Legacy NDC, 3 package rows20231214_69410bf3-0d3a-41f9-b10a-c4ee3770f728.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049696oxyCODONE HCl 5 MG Oral CapsulePSN69410bf3-0d3a-41f9-b10a-c4ee3770f7287
1049696oxycodone hydrochloride 5 MG Oral CapsuleSCD69410bf3-0d3a-41f9-b10a-c4ee3770f7287

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
40032-950-0140032095001100 CAPSULE in 1 BOTTLE (40032-950-01) 100 capsule2015-08-24NoNoHistorical
40032-950-034003209500330 CAPSULE in 1 BOTTLE (40032-950-03) 30 capsule2015-08-24NoNoHistorical
40032-950-5040032095050500 CAPSULE in 1 BOTTLE (40032-950-50) 500 capsule2015-08-24NoNoHistorical