Home NDC 0406-8515 OXYCODONE HYDROCHLORIDE
Product NDC 0406-8515
11-digit product format 004068515
Labeler code 0406
Product ID 0406-8515_d2534006-67e9-4e2a-a4f8-1e44d5857af5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxycodone hydrochloride
Dosage form TABLET
Route ORAL
Labeler SpecGx LLC
Application ANDA076758
Marketing category ANDA
Marketing start 2004-06-30
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 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076758-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2004-06-30 A076758-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2004-06-30 A076758-003 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2007-03-19 A076758-004 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-10-12 A076758-005 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 5 · 194 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 A076758-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2004-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076758-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2004-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076758-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2007-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076758-004 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076758-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076758-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2004-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076758-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2004-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076758-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2007-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076758-004 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076758-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076758-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2004-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076758-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2004-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076758-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2007-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076758-004 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076758-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076758-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2004-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076758-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2004-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076758-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2007-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076758-004 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076758-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076758-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2004-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076758-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2004-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076758-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2007-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076758-004 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076758-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076758-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2004-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076758-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2004-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076758-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2007-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076758-004 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076758-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076758-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2004-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076758-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2004-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076758-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2007-03-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076758-004 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076758-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076758-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2004-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076758-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2004-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076758-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2007-03-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076758-004 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076758-005 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-10-12 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 194 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 15 mg/1
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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049611 Internal RxNorm lookup 1049618 Internal RxNorm lookup 1049621 Internal RxNorm lookup 1049683 Internal RxNorm lookup 1049686 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 0406-8515-01 OXYCODONE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 35 0406-8515-23 OXYCODONE HYDROCHLORIDE 1 in 1 BLISTER PACK TABLET 1 35 0406-8515-62 OXYCODONE HYDROCHLORIDE 100 in 1 BLISTER PACK TABLET 100 35
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 11 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 11 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 11 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 11 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 11 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP OXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 11 OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYCODONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXYCODONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXYCODONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP OXYCODONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2
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 · 3 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 0406-8515-01 00406851501 100 TABLET in 1 BOTTLE (0406-8515-01) 100 tablet 2004-06-30 0000-00-00 No No Current 0406-8515-23 00406851523 1 TABLET in 1 BLISTER PACK (0406-8515-23) 1 tablet 2004-06-30 0000-00-00 No No Current 0406-8515-62 00406851562 100 TABLET in 1 BLISTER PACK (0406-8515-62) 100 tablet 2004-06-30 0000-00-00 No No Current