Home NDC 71930-022 Oxycodone Hydrochloride
Product NDC 71930-022
11-digit product format 719300022
Labeler code 71930
Product ID 71930-022_d5dbbf3c-6269-488c-b3a2-9539f45e3945
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Eywa Pharma Inc
Application ANDA207511
Marketing category ANDA
Marketing start 2019-03-01
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 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 A207511-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207511-001 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 · 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 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207511-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2016-11-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 71930-022-43 Oxycodone Hydrochloride 1 in 1 CARTON SOLUTION 1 7 71930-022-43 Oxycodone Hydrochloride 473 mL in 1 BOTTLE SOLUTION 473 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71930-022 OXYCODONE HYDROCHLORIDE SOLUTION [EYWA PHARMA INC] 6 Current NDC, Legacy NDC, 2 package rows 20241222_685f409f-946f-4b7e-8130-5ad7b92a5e7a.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE MAJOR PHARMACEUTICALS e4fbf3fd-8755-4699-9a61-ba7fada0f93f 2026-02-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207511 application number: ANDA207511 Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE Eywa Pharma Inc 685f409f-946f-4b7e-8130-5ad7b92a5e7a 2026-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207511 application number: ANDA207511 ndc (product): 71930-022 Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE MAJOR PHARMACEUTICALS 6d249bc5-79c4-4c42-a71b-d667c75163db 2026-01-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207511 application number: ANDA207511 Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE Bryant Ranch Prepack e2e52a0e-a80b-4225-b034-37a62f839d92 2025-01-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207511 application number: ANDA207511
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 71930-022-43 71930002243 1 BOTTLE in 1 CARTON (71930-022-43) / 473 mL in 1 BOTTLE 1 bottle 2019-03-01 0000-00-00 No No Current