Home NDC 0527-1426 Oxycodone Hydrochloride
Product NDC 0527-1426
11-digit product format 005271426
Labeler code 0527
Product ID 0527-1426_ce2892ff-d5cb-4973-a141-f1c5c765fa7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA204085
Marketing category ANDA
Marketing start 2014-09-10
Marketing end 0000-00-00
Substance OXYCODONE HYDROCHLORIDE
Active strength 100 mg/5mL
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2019-12-31
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 1 · 51 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0527-1426-36 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0527-1426-35 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0527-1426-36 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0527-1426-35 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0527-1426-36 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0527-1426-35 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0527-1426-36 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0527-1426-35 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0527-1426-36 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0527-1426-35 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0527-1426-36 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0527-1426-35 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0527-1426-36 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0527-1426-35 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0527-1426-36 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0527-1426-35 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0527-1426-36 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0527-1426-35 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0527-1426-36 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0527-1426-35 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0527-1426-36 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0527-1426-35 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0527-1426-36 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0527-1426-35 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0527-1426-36 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0527-1426-35 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0527-1426-36 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0527-1426-35 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0527-1426-36 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0527-1426-35 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0527-1426-36 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0527-1426-35 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0527-1426-36 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0527-1426-35 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204085-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09
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 2 · 41 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 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204085-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2014-09-09 cb3db0bc1861…
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0527-1426-35 2022-05-26 These highlights do not include all the information needed to use oxycodone hydrochloride oral solution safely and effectively. See full prescribing information for oxycodone hydrochloride oral solution. OXYCODONE Hydrochloride Oral Solution USP, for oral use, CII Initial U.S. Approval: 1950 0527-1426-36 2022-05-26 These highlights do not include all the information needed to use oxycodone hydrochloride oral solution safely and effectively. See full prescribing information for oxycodone hydrochloride oral solution. OXYCODONE Hydrochloride Oral Solution USP, for oral use, CII Initial U.S. Approval: 1950 0527-1426-35 2020-01-31 These highlights do not include all the information needed to use oxycodone hydrochloride oral solution safely and effectively. See full prescribing information for oxycodone hydrochloride oral solution. OXYCODONE Hydrochloride Oral Solution USP, for oral use, CII Initial U.S. Approval: 1950 0527-1426-36 2020-01-31 These highlights do not include all the information needed to use oxycodone hydrochloride oral solution safely and effectively. See full prescribing information for oxycodone hydrochloride oral solution. OXYCODONE Hydrochloride Oral Solution USP, for oral use, CII Initial U.S. Approval: 1950
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 MALTITOL INACTIVE INGREDIENT D65DG142WK OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 SODIUM GLUCONATE INACTIVE INGREDIENT R6Q3791S76 OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 SORBITOL INACTIVE INGREDIENT 506T60A25R OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20 WATER INACTIVE INGREDIENT 059QF0KO0R OXYCODONE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 20