Home NDC 61919-479 OXYCODONE HYDROCHLORIDE
Product NDC 61919-479
11-digit product format 619190479
Labeler code 61919
Product ID 61919-479_92d9199c-7efe-8db7-e053-2995a90a87c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXYCODONE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Direct_Rx
Application ANDA202662
Marketing category ANDA
Marketing start 2018-03-12
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202662-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 A202662-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 A202662-003 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2015-09-22 A202662-004 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2015-09-22 A202662-005 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 210 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 2026-08-18 06:07:40 2026-07 A202662-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202662-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202662-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2015-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202662-004 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2015-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202662-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202662-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202662-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202662-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2015-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202662-004 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2015-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202662-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202662-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202662-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202662-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2015-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202662-004 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2015-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202662-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202662-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202662-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202662-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2015-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202662-004 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2015-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202662-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202662-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202662-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202662-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2015-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202662-004 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2015-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202662-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202662-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202662-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202662-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2015-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202662-004 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2015-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202662-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202662-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202662-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202662-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2015-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202662-004 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2015-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202662-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202662-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202662-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202662-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2015-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202662-004 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2015-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202662-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-04-27 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 observed states.
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 · 1 matching rows.