Home NDC 23635-582 Roxicodone
Product NDC 23635-582
11-digit product format 236350582
Labeler code 23635
Product ID 23635-582_9c646c9c-3074-4250-8191-82ac61b515a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxycodone hydrochloride
Dosage form TABLET
Route ORAL
Labeler SpecGx LLC
Application NDA021011
Marketing category NDA
Marketing start 2000-08-31
Substance OXYCODONE HYDROCHLORIDE
Active strength 30 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021011-001 ROXICODONE OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 N021011-002 ROXICODONE OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB RLD 2000-08-31 N021011-003 ROXICODONE OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB RLD 2009-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Roxicodone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 30 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049611 Internal RxNorm lookup 1049613 Internal RxNorm lookup 1049618 Internal RxNorm lookup 1049620 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 23635-582-10 Roxicodone 100 in 1 BOTTLE, PLASTIC TABLET 100 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] 4 OXYCODONE ACTIVE MOIETY CD35PMG570 ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23635-582 ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [SPECGX LLC] 28 Current NDC, Legacy NDC, 1 package rows 20240426_5a8157d3-ba20-4abf-b0d4-6ad141b31d63.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 Units Marketing start Marketing end Sample Exclude flag Status 23635-582-10 23635058210 100 TABLET in 1 BOTTLE, PLASTIC (23635-582-10) 100 tablet 2000-08-31 0000-00-00 No No Current