Home NDC 0054-0390 oxycodone hydrochloride
Product NDC 0054-0390
11-digit product format 000540390
Labeler code 0054
Product ID 0054-0390_47e856d4-de7d-49aa-8671-d1b4a35bad4d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxycodone hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmceuticals USA Inc.
Application ANDA204037
Marketing category ANDA
Marketing start 2014-09-04
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A204037-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204037-001 AA
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 · 42 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 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RS 2013-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204037-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2013-07-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base oxycodone hydrochloride
Listing expiration 2027-12-31 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 0054-0390-41 oxycodone hydrochloride 15 mL in 1 BOTTLE SOLUTION 15 18 0054-0390-63 oxycodone hydrochloride 500 mL in 1 BOTTLE SOLUTION 500 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 1 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0390 OXYCODONE HYDROCHLORIDE SOLUTION [HIKMA PHARMCEUTICALS USA INC.] 12 Current NDC, Legacy NDC, 2 package rows 20240509_d8e87c66-f872-4e1d-9ade-ef11490af63b.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.
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 0054-0390-41 00054039041 15 mL in 1 BOTTLE (0054-0390-41) 15 ml 2014-09-04 2026-08-31 No No Current 0054-0390-63 00054039063 500 mL in 1 BOTTLE (0054-0390-63) 500 ml 2014-09-04 0000-00-00 No No Current