FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
71335-1414
11-digit product format
713351414
Labeler code
71335
Product ID
71335-1414_2cfad061-5173-4a0f-a519-daeff881cd29
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
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049618

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
71335-1414-1Oxycodone Hydrochloride60 in 1 BOTTLETABLET60105
71335-1414-2Oxycodone Hydrochloride90 in 1 BOTTLETABLET90105
71335-1414-3Oxycodone Hydrochloride120 in 1 BOTTLETABLET120105
71335-1414-4Oxycodone Hydrochloride30 in 1 BOTTLETABLET30105
71335-1414-5Oxycodone Hydrochloride100 in 1 BOTTLETABLET100105
71335-1414-6Oxycodone Hydrochloride40 in 1 BOTTLETABLET40105
71335-1414-7Oxycodone Hydrochloride18 in 1 BOTTLETABLET18105
71335-1414-8Oxycodone Hydrochloride28 in 1 BOTTLETABLET28105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1414-1EA - Each71335-1414b6d08245-948e-4f26-a5ab-bca3149093b512020-09-14
71335-1414-2EA - Each71335-14145363aa2f-08ca-4670-a1a4-37b5a60d1fb712020-09-14
71335-1414-4EA - Each71335-141462779ed2-1de1-4953-aa0e-7594a1a547d612020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1414OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 8 package rows20241122_d9841f2d-d182-4888-9a3c-68e1afb3e19c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049618oxyCODONE HCl 30 MG Oral TabletPSNd9841f2d-d182-4888-9a3c-68e1afb3e19c105
1049618oxycodone hydrochloride 30 MG Oral TabletSCDd9841f2d-d182-4888-9a3c-68e1afb3e19c105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1414-17133514140160 TABLET in 1 BOTTLE (71335-1414-1) 60 tablet2019-12-200000-00-00NoNoCurrent
71335-1414-27133514140290 TABLET in 1 BOTTLE (71335-1414-2) 90 tablet2019-12-130000-00-00NoNoCurrent
71335-1414-371335141403120 TABLET in 1 BOTTLE (71335-1414-3) 120 tablet2024-07-090000-00-00NoNoCurrent
71335-1414-47133514140430 TABLET in 1 BOTTLE (71335-1414-4) 30 tablet2019-12-100000-00-00NoNoCurrent
71335-1414-571335141405100 TABLET in 1 BOTTLE (71335-1414-5) 100 tablet2024-07-090000-00-00NoNoCurrent
71335-1414-67133514140640 TABLET in 1 BOTTLE (71335-1414-6) 40 tablet2024-07-090000-00-00NoNoCurrent
71335-1414-77133514140718 TABLET in 1 BOTTLE (71335-1414-7) 18 tablet2024-07-090000-00-00NoNoCurrent
71335-1414-87133514140828 TABLET in 1 BOTTLE (71335-1414-8) 28 tablet2024-07-090000-00-00NoNoCurrent