Home NDC 69238-2300 Oxycodone HCl
Product NDC 69238-2300
11-digit product format 692382300
Labeler code 69238
Product ID 69238-2300_c454eaf2-d0a9-4c3f-84e1-86b1b6973172
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone HCl
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application NDA022272
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-04-01
Marketing end 0000-00-00
Substance OXYCODONE HYDROCHLORIDE
Active strength 80 mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022272-001 OXYCONTIN OXYCODONE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 N022272-002 OXYCONTIN OXYCODONE HYDROCHLORIDE 15MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 N022272-003 OXYCONTIN OXYCODONE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 N022272-004 OXYCONTIN OXYCODONE HYDROCHLORIDE 30MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 N022272-005 OXYCONTIN OXYCODONE HYDROCHLORIDE 40MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2010-04-05 N022272-006 OXYCONTIN OXYCODONE HYDROCHLORIDE 60MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 N022272-007 OXYCONTIN OXYCODONE HYDROCHLORIDE 80MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05
Orange Book patents# Current patent rows page 1 of 2 · 102 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 8 · 301 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 N022272-001 OXYCONTIN 10MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 OXYCONTIN 15MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 OXYCONTIN 20MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-004 OXYCONTIN 30MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-005 OXYCONTIN 40MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2010-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-006 OXYCONTIN 60MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-007 OXYCONTIN 80MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022272-001 OXYCONTIN 10MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022272-002 OXYCONTIN 15MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022272-003 OXYCONTIN 20MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022272-004 OXYCONTIN 30MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022272-005 OXYCONTIN 40MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2010-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022272-006 OXYCONTIN 60MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022272-007 OXYCONTIN 80MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022272-001 OXYCONTIN 10MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022272-002 OXYCONTIN 15MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022272-003 OXYCONTIN 20MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022272-004 OXYCONTIN 30MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022272-005 OXYCONTIN 40MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2010-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022272-006 OXYCONTIN 60MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022272-007 OXYCONTIN 80MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022272-001 OXYCONTIN 10MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022272-002 OXYCONTIN 15MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022272-003 OXYCONTIN 20MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022272-004 OXYCONTIN 30MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022272-005 OXYCONTIN 40MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2010-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022272-006 OXYCONTIN 60MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022272-007 OXYCONTIN 80MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022272-001 OXYCONTIN 10MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022272-002 OXYCONTIN 15MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022272-003 OXYCONTIN 20MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022272-004 OXYCONTIN 30MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022272-005 OXYCONTIN 40MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2010-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022272-006 OXYCONTIN 60MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022272-007 OXYCONTIN 80MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022272-001 OXYCONTIN 10MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022272-002 OXYCONTIN 15MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022272-003 OXYCONTIN 20MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022272-004 OXYCONTIN 30MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022272-005 OXYCONTIN 40MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2010-04-05 fd3edfee7708…
Observed Orange Book patent history# Patent history page 1 of 139 · 5,544 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022272-001 11304908 2027-08-24 Drug product 2022-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 11304909 2027-08-24 U-1556 2022-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 11964056 2027-08-24 Drug product 2024-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 12246094 2027-08-24 Drug product 2025-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 12280152 2027-08-24 Drug product 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 8808741 2027-08-24 U-1556 2014-08-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 8894988 2027-08-24 Drug product 2014-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 9492389 2027-08-24 Drug product 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 9492391 2027-08-24 U-1556 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 9492392 2027-08-24 Drug product 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 9492393 2027-08-24 U-1556 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 9763933 2027-08-24 Drug product 2017-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 9770416 2027-08-24 Drug product 2017-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 9775808 2027-08-24 Drug product 2017-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-001 8894987 2030-03-29 Drug product 2014-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 11304908 2027-08-24 Drug product 2022-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 11304909 2027-08-24 U-1556 2022-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 11964056 2027-08-24 Drug product 2024-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 12246094 2027-08-24 Drug product 2025-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 12280152 2027-08-24 Drug product 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 8808741 2027-08-24 U-1556 2014-08-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 8894988 2027-08-24 Drug product 2014-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 9492389 2027-08-24 Drug product 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 9492391 2027-08-24 U-1556 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 9492392 2027-08-24 Drug product 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 9492393 2027-08-24 U-1556 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 9763933 2027-08-24 Drug product 2017-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 9770416 2027-08-24 Drug product 2017-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 9775808 2027-08-24 Drug product 2017-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-002 8894987 2030-03-29 Drug product 2014-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 11304908 2027-08-24 Drug product 2022-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 11304909 2027-08-24 U-1556 2022-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 11964056 2027-08-24 Drug product 2024-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 12246094 2027-08-24 Drug product 2025-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 12280152 2027-08-24 Drug product 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 8808741 2027-08-24 U-1556 2014-08-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 8894988 2027-08-24 Drug product 2014-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 9492389 2027-08-24 Drug product 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 9492391 2027-08-24 U-1556 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022272-003 9492392 2027-08-24 Drug product 2016-11-16 84e616aacf4f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-2300 OXYCODONE HCL TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] 6 Legacy NDC 20231231_8220e596-f32e-49cf-a11c-0c79209c3633.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69238-2300-1 69238230001 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2300-1) 2022-04-01 0000-00-00 No No Current