FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
65162-048
11-digit product format
651620048
Labeler code
65162
Product ID
65162-048_8b9e3253-7735-44cc-a59b-3125ab573c84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA203638
Marketing category
ANDA
Marketing start
2012-10-30
Substance
OXYCODONE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049611, 1049618, 1049621, 1049683, 1049686

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
65162-048-03Oxycodone Hydrochloride30 in 1 BOTTLETABLET3020
65162-048-10Oxycodone Hydrochloride100 in 1 BOTTLETABLET10020
65162-048-25Oxycodone Hydrochloride250 in 1 BOTTLETABLET25020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-048-10EA - Each65162-0485c5d63cf-2149-4dbf-a691-de96c348436412014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KOXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-048OXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS LLC]20Current NDC, Legacy NDC, 3 package rows20240504_094b64b3-cd32-4de5-afb6-ea00d9caad74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049683oxyCODONE HCl 10 MG Oral TabletPSN094b64b3-cd32-4de5-afb6-ea00d9caad7420
1049611oxyCODONE HCl 15 MG Oral TabletPSN094b64b3-cd32-4de5-afb6-ea00d9caad7420
1049686oxyCODONE HCl 20 MG Oral TabletPSN094b64b3-cd32-4de5-afb6-ea00d9caad7420
1049618oxyCODONE HCl 30 MG Oral TabletPSN094b64b3-cd32-4de5-afb6-ea00d9caad7420
1049621oxyCODONE HCl 5 MG Oral TabletPSN094b64b3-cd32-4de5-afb6-ea00d9caad7420
1049683oxycodone hydrochloride 10 MG Oral TabletSCD094b64b3-cd32-4de5-afb6-ea00d9caad7420
1049611oxycodone hydrochloride 15 MG Oral TabletSCD094b64b3-cd32-4de5-afb6-ea00d9caad7420
1049686oxycodone hydrochloride 20 MG Oral TabletSCD094b64b3-cd32-4de5-afb6-ea00d9caad7420
1049618oxycodone hydrochloride 30 MG Oral TabletSCD094b64b3-cd32-4de5-afb6-ea00d9caad7420
1049621oxycodone hydrochloride 5 MG Oral TabletSCD094b64b3-cd32-4de5-afb6-ea00d9caad7420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-048-036516200480330 TABLET in 1 BOTTLE (65162-048-03) 30 tablet2012-10-300000-00-00NoNoCurrent
65162-048-1065162004810100 TABLET in 1 BOTTLE (65162-048-10) 100 tablet2012-10-300000-00-00NoNoCurrent
65162-048-2565162004825250 TABLET in 1 BOTTLE (65162-048-25) 250 tablet2012-10-300000-00-00NoNoCurrent