Home NDC 67296-2167 Oxycodone Hydrochloride
Product NDC 67296-2167
11-digit product format 672962167
Labeler code 67296
Product ID 67296-2167_45abe234-8d2e-b01a-e063-6294a90a7789
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Redpharm Drug
Application NDA200535
Marketing category NDA
Marketing start 2013-09-09
Substance OXYCODONE HYDROCHLORIDE
Active strength 5 mg/5mL
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N200535-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 N200535-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 2026-09-14 22:38:34 2026-08 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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/5mL
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 1049604 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-2167-6 Oxycodone Hydrochloride 60 mL in 1 BOTTLE, PLASTIC SOLUTION 60 4 67296-2167-6 Oxycodone Hydrochloride 1 in 1 CARTON SOLUTION 1 4
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67296-2167-6 67296216706 1 BOTTLE, PLASTIC in 1 CARTON (67296-2167-6) / 60 mL in 1 BOTTLE, PLASTIC 2013-09-09 No No Current