Home NDC 23635-580 Roxicodone
Product NDC 23635-580
11-digit product format 236350580
Labeler code 23635
Product ID 23635-580_b3f53f09-febd-4a6f-b7c0-cb932016ca9c
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
Marketing end 0000-00-00
Substance OXYCODONE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Roxicodone OXYCODONE HYDROCHLORIDE SpecGx LLC 5a8157d3-ba20-4abf-b0d4-6ad141b31d63 2026-04-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021011 application number: NDA021011
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 23635-580-10 23635058010 100 TABLET in 1 BOTTLE, PLASTIC (23635-580-10) 100 tablet 2000-08-31 0000-00-00 No No Current 23635-580-25 23635058025 4 BLISTER PACK in 1 CARTON (23635-580-25) > 25 TABLET in 1 BLISTER PACK 4 blister pack 2000-08-31 0000-00-00 No No Current