Home NDC 61919-659 OXYCODONE HCL
Product NDC 61919-659
11-digit product format 619190659
Labeler code 61919
Product ID 61919-659_9cab4be0-9868-c53d-e053-2a95a90a6b29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXYCODONE HCL
Dosage form TABLET
Route ORAL
Labeler DIRECT RX
Application ANDA090659
Marketing category ANDA
Marketing start 2016-02-22
Marketing end 0000-00-00
Substance OXYCODONE HYDROCHLORIDE
Active strength 15 mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record
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 2 · 82 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-659-60 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-659-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-659-60 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-659-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-659-60 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-659-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-659-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-659-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-659-60 cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-659-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-659-60 cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-659-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-659-60 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-659-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-659-60 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-659-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-659-60 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-659-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61919-659-60 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61919-659-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61919-659-60 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61919-659-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61919-659-60 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61919-659-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 61919-659-60 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 61919-659-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 61919-659-60 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 61919-659-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 61919-659-60 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 61919-659-30 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090659-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 A090659-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 A090659-003 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 A090659-004 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 A090659-005 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06
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 · 215 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 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 140 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-659-30 OXYCODONE HCL 30 in 1 BOTTLE TABLET 30 2 61919-659-60 Oxycodone HCL 60 in 1 BOTTLE TABLET 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-659 OXYCODONE HCL TABLET [DIRECT RX] 2 Legacy NDC, 1 package rows 20200131_2c6296ee-779a-419b-e054-00144ff8d46c.zip 61919-659 OXYCODONE HCL TABLET [DIRECT RX] 1 Legacy NDC, 1 package rows 20160218_2b48c2dd-e62e-4f53-e054-00144ff88e88.zip
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 61919-659-30 61919065930 30 TABLET in 1 BOTTLE (61919-659-30) 30 tablet 2016-02-22 0000-00-00 No No Current 61919-659-60 61919065960 60 in 1 BOTTLE Historical