FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
71335-1413
11-digit product format
713351413
Labeler code
71335
Product ID
71335-1413_d82f357a-4209-4bb3-85b7-60c59f7b8ae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091490
Marketing category
ANDA
Marketing start
2014-09-08
Substance
OXYCODONE HYDROCHLORIDE
Active strength
15 mg/1
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 HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049611

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
71335-1413-1Oxycodone Hydrochloride60 in 1 BOTTLETABLET6013
71335-1413-2Oxycodone Hydrochloride90 in 1 BOTTLETABLET9013
71335-1413-3Oxycodone Hydrochloride30 in 1 BOTTLETABLET3013
71335-1413-4Oxycodone Hydrochloride120 in 1 BOTTLETABLET12013
71335-1413-5Oxycodone Hydrochloride100 in 1 BOTTLETABLET10013
71335-1413-6Oxycodone Hydrochloride56 in 1 BOTTLETABLET5613
71335-1413-7Oxycodone Hydrochloride84 in 1 BOTTLETABLET8413
71335-1413-8Oxycodone Hydrochloride45 in 1 BOTTLETABLET4513
71335-1413-9Oxycodone Hydrochloride18 in 1 BOTTLETABLET1813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1413-1EA - Each71335-14136c3257a8-79cb-4930-89b0-0c84ac11c46c12025-03-04
71335-1413-2EA - Each71335-141381614ff8-caac-4141-bd31-9899eb2b528612026-04-20
71335-1413-3EA - Each71335-14133e4078d6-5791-4103-8dda-07091972534712025-03-04
71335-1413-5EA - Each71335-1413bb9ca1c2-4731-40f6-b307-ebff0152963f12026-04-20
71335-1413-6EA - Each71335-1413973b9e99-c03d-4c84-979c-b85ab6cabce712026-04-20
71335-1413-7EA - Each71335-141347376f81-f814-41d9-a5a3-5c6806d52c7f12026-04-20
71335-1413-8EA - Each71335-1413210ec36f-e5e1-4950-823e-37cedd3fd26f12026-04-20
71335-1413-9EA - Each71335-1413b108ce1a-0989-4b2b-9201-c77c7efcd94512026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049611oxyCODONE HCl 15 MG Oral TabletPSN1a190488-3444-43b0-b9c8-45c1eb371aad13
1049611oxycodone hydrochloride 15 MG Oral TabletSCD1a190488-3444-43b0-b9c8-45c1eb371aad13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1413-17133514130160 TABLET in 1 BOTTLE (71335-1413-1) 60 tablet2020-02-030000-00-00NoNoCurrent
71335-1413-27133514130290 TABLET in 1 BOTTLE (71335-1413-2) 90 tablet2020-07-060000-00-00NoNoCurrent
71335-1413-37133514130330 TABLET in 1 BOTTLE (71335-1413-3) 30 tablet2020-03-230000-00-00NoNoCurrent
71335-1413-471335141304120 TABLET in 1 BOTTLE (71335-1413-4) 120 tablet2019-12-310000-00-00NoNoCurrent
71335-1413-571335141305100 TABLET in 1 BOTTLE (71335-1413-5) 100 tablet2024-07-090000-00-00NoNoCurrent
71335-1413-67133514130656 TABLET in 1 BOTTLE (71335-1413-6) 56 tablet2024-07-090000-00-00NoNoCurrent
71335-1413-77133514130784 TABLET in 1 BOTTLE (71335-1413-7) 84 tablet2024-07-090000-00-00NoNoCurrent
71335-1413-87133514130845 TABLET in 1 BOTTLE (71335-1413-8) 45 tablet2024-07-090000-00-00NoNoCurrent
71335-1413-97133514130918 TABLET in 1 BOTTLE (71335-1413-9) 18 tablet2024-07-090000-00-00NoNoCurrent