Home NDC 0406-8557 Oxycodone Hydrochloride
Product NDC 0406-8557
11-digit product format 004068557
Labeler code 0406
Product ID 0406-8557_7e788fe5-6049-4ff6-a09a-60e8b9e52d9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler SpecGx LLC
Application ANDA210758
Marketing category ANDA
Marketing start 2018-04-30
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 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210758-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 A210758-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 84 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 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210758-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2018-04-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210758-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA 2018-04-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxycodone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 100 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049604 Internal RxNorm lookup 1049615 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 0406-8557-30 Oxycodone Hydrochloride 1 in 1 CARTON SOLUTION 1 23 0406-8557-30 Oxycodone Hydrochloride 30 mL in 1 BOTTLE, PLASTIC SOLUTION 30 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-8557 OXYCODONE HYDROCHLORIDE SOLUTION [SPECGX LLC] 21 Current NDC, Legacy NDC, 2 package rows 20240906_5451bcaa-0aca-4581-bcea-2f9c2a33b260.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0406-8557-30 00406855730 1 BOTTLE, PLASTIC in 1 CARTON (0406-8557-30) / 30 mL in 1 BOTTLE, PLASTIC 2018-04-30 0000-00-00 No No Current