Home NDC 71335-1361-4 Oxycodone Hydrochloride
Product NDC 71335-1361
Requested package NDC 71335-1361-4
11-digit product format 713351361
Labeler code 71335
Product ID 71335-1361_54e9825a-c175-412a-911d-0930609a5c9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA202160
Marketing category ANDA
Marketing start 2012-07-12
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202160-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 A202160-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 A202160-003 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202160-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2012-11-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202160-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2012-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202160-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxycodone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C1ENJ2TE6C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049621 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-1361-1 2024-08-21 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-2 2024-08-21 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-3 2024-08-21 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-4 2024-08-21 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-5 2024-08-21 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-6 2024-08-21 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-7 2024-08-21 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-8 2024-08-21 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-9 2024-08-21 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-1 2024-01-30 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-2 2024-01-30 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-3 2024-01-30 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-4 2024-01-30 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-5 2024-01-30 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-6 2024-01-30 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-7 2024-01-30 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-8 2024-01-30 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950 71335-1361-9 2024-01-30 These highlights do not include all the information needed to use Oxycodone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets. Oxycodone Hydrochloride Tablets, for oral use, CII Initial U.S. Approval: 1950
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1361-0 Oxycodone Hydrochloride 15 in 1 BOTTLE TABLET 15 3 71335-1361-1 Oxycodone Hydrochloride 30 in 1 BOTTLE TABLET 30 3 71335-1361-2 Oxycodone Hydrochloride 60 in 1 BOTTLE TABLET 60 3 71335-1361-3 Oxycodone Hydrochloride 90 in 1 BOTTLE TABLET 90 3 71335-1361-4 Oxycodone Hydrochloride 56 in 1 BOTTLE TABLET 56 3 71335-1361-5 Oxycodone Hydrochloride 100 in 1 BOTTLE TABLET 100 3 71335-1361-6 Oxycodone Hydrochloride 120 in 1 BOTTLE TABLET 120 3 71335-1361-7 Oxycodone Hydrochloride 50 in 1 BOTTLE TABLET 50 3 71335-1361-8 Oxycodone Hydrochloride 40 in 1 BOTTLE TABLET 40 3 71335-1361-9 Oxycodone Hydrochloride 20 in 1 BOTTLE TABLET 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1361 OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 3 Current NDC, Legacy NDC, 10 package rows 20240823_261132f9-ab96-4901-a660-a80c3e0f9d86.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. bdade691-3687-3308-e053-2995a90ad6ed 2026-02-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202160 application number: ANDA202160 Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE Aurolife Pharma, LLC 96ad4352-fff3-46a7-85de-466cc161045e 2025-12-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202160 application number: ANDA202160 Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE Bryant Ranch Prepack 261132f9-ab96-4901-a660-a80c3e0f9d86 2024-08-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202160 application number: ANDA202160 ndc (package): 71335-1361-4 ndc (product): 71335-1361 ndc11 (package): 71335136104
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-1361-4 71335136104 56 TABLET in 1 BOTTLE (71335-1361-4) 56 tablet 2024-08-12 0000-00-00 No No Current