FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
71335-1421
11-digit product format
713351421
Labeler code
71335
Product ID
71335-1421_86ab7d29-049d-4d6a-aad4-9d1664442d82
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
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
Rxcui1049621

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
71335-1421-0Oxycodone Hydrochloride15 in 1 BOTTLETABLET15105
71335-1421-1Oxycodone Hydrochloride30 in 1 BOTTLETABLET30105
71335-1421-2Oxycodone Hydrochloride60 in 1 BOTTLETABLET60105
71335-1421-3Oxycodone Hydrochloride90 in 1 BOTTLETABLET90105
71335-1421-4Oxycodone Hydrochloride56 in 1 BOTTLETABLET56105
71335-1421-5Oxycodone Hydrochloride100 in 1 BOTTLETABLET100105
71335-1421-6Oxycodone Hydrochloride120 in 1 BOTTLETABLET120105
71335-1421-7Oxycodone Hydrochloride50 in 1 BOTTLETABLET50105
71335-1421-8Oxycodone Hydrochloride40 in 1 BOTTLETABLET40105
71335-1421-9Oxycodone Hydrochloride20 in 1 BOTTLETABLET20105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1421-1EA - Each71335-14212efaf855-1302-44ac-92d5-9b5c2749ed0a12020-07-13
71335-1421-2EA - Each71335-14212894f555-b613-4569-8521-390a3bcc414712020-09-14
71335-1421-3EA - Each71335-1421e3d583dd-ef67-4560-b1d8-77f0559b4ea712020-07-13
71335-1421-9EA - Each71335-1421ff5f8853-a705-4093-b568-a64633299d4f12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1421OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 10 package rows20240829_1bcddbe1-c453-43ec-a822-9e993b885a5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049621oxyCODONE HCl 5 MG Oral TabletPSN1bcddbe1-c453-43ec-a822-9e993b885a5f105
1049621oxycodone hydrochloride 5 MG Oral TabletSCD1bcddbe1-c453-43ec-a822-9e993b885a5f105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1421-07133514210015 TABLET in 1 BOTTLE (71335-1421-0) 15 tablet2024-07-02NoNoCurrent
71335-1421-17133514210130 TABLET in 1 BOTTLE (71335-1421-1) 30 tablet2019-12-130000-00-00NoNoCurrent
71335-1421-27133514210260 TABLET in 1 BOTTLE (71335-1421-2) 60 tablet2019-12-160000-00-00NoNoCurrent
71335-1421-37133514210390 TABLET in 1 BOTTLE (71335-1421-3) 90 tablet2019-12-160000-00-00NoNoCurrent
71335-1421-47133514210456 TABLET in 1 BOTTLE (71335-1421-4) 56 tablet2024-07-090000-00-00NoNoCurrent
71335-1421-571335142105100 TABLET in 1 BOTTLE (71335-1421-5) 100 tablet2024-07-090000-00-00NoNoCurrent
71335-1421-671335142106120 TABLET in 1 BOTTLE (71335-1421-6) 120 tablet2020-09-210000-00-00NoNoCurrent
71335-1421-77133514210750 TABLET in 1 BOTTLE (71335-1421-7) 50 tablet2024-07-090000-00-00NoNoCurrent
71335-1421-87133514210840 TABLET in 1 BOTTLE (71335-1421-8) 40 tablet2024-07-090000-00-00NoNoCurrent
71335-1421-97133514210920 TABLET in 1 BOTTLE (71335-1421-9) 20 tablet2019-12-060000-00-00NoNoCurrent