Home NDC 81140-103 RoxyBond
Product NDC 81140-103
11-digit product format 811400103
Labeler code 81140
Product ID 81140-103_484b1240-1832-049e-e063-6394a90aaa6a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Protega Pharmaceuticals Inc
Application NDA209777
Marketing category NDA
Marketing start 2017-04-20
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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209777-001 ROXYBOND OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-04-20 N209777-002 ROXYBOND OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-04-20 N209777-003 ROXYBOND OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-04-20 N209777-004 ROXYBOND OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2024-09-05
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209777-001 10314788 2028-08-12 Drug product 2019-07-10 N209777-001 7955619 2028-08-12 Drug product 2017-05-19 N209777-002 10314788 2028-08-12 Drug product 2019-07-10 N209777-002 7955619 2028-08-12 Drug product 2017-05-19 N209777-003 10314788 2028-08-12 Drug product 2019-07-10 N209777-003 7955619 2028-08-12 Drug product 2017-05-19 N209777-004 10314788 2028-08-12 Drug product 2024-10-04 N209777-004 7955619 2028-08-12 Drug product 2024-10-04
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 · 141 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 2026-09-14 22:38:34 2026-08 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209777-002 ROXYBOND 15MG TABLET / ORAL 2017-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209777-003 ROXYBOND 30MG TABLET / ORAL 2017-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209777-004 ROXYBOND 10MG TABLET / ORAL 2024-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209777-002 ROXYBOND 15MG TABLET / ORAL 2017-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209777-003 ROXYBOND 30MG TABLET / ORAL 2017-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209777-004 ROXYBOND 10MG TABLET / ORAL 2024-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209777-002 ROXYBOND 15MG TABLET / ORAL 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209777-003 ROXYBOND 30MG TABLET / ORAL 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209777-004 ROXYBOND 10MG TABLET / ORAL 2024-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-002 ROXYBOND 15MG TABLET / ORAL 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-003 ROXYBOND 30MG TABLET / ORAL 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-004 ROXYBOND 10MG TABLET / ORAL 2024-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209777-002 ROXYBOND 15MG TABLET / ORAL 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209777-003 ROXYBOND 30MG TABLET / ORAL 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209777-004 ROXYBOND 10MG TABLET / ORAL 2024-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209777-002 ROXYBOND 15MG TABLET / ORAL 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209777-003 ROXYBOND 30MG TABLET / ORAL 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209777-004 ROXYBOND 10MG TABLET / ORAL 2024-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209777-002 ROXYBOND 15MG TABLET / ORAL 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209777-003 ROXYBOND 30MG TABLET / ORAL 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209777-004 ROXYBOND 10MG TABLET / ORAL 2024-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209777-002 ROXYBOND 15MG TABLET / ORAL 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209777-003 ROXYBOND 30MG TABLET / ORAL 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209777-004 ROXYBOND 10MG TABLET / ORAL 2024-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209777-002 ROXYBOND 15MG TABLET / ORAL 2017-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209777-003 ROXYBOND 30MG TABLET / ORAL 2017-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209777-004 ROXYBOND 10MG TABLET / ORAL 2024-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209777-002 ROXYBOND 15MG TABLET / ORAL 2017-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209777-003 ROXYBOND 30MG TABLET / ORAL 2017-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209777-001 ROXYBOND 5MG TABLET / ORAL 2017-04-20 d8e5a09893c0…
Observed Orange Book patent history# Patent history page 1 of 8 · 282 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N209777-001 10314788 2028-08-12 Drug product 2019-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209777-001 7955619 2028-08-12 Drug product 2017-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209777-002 10314788 2028-08-12 Drug product 2019-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209777-002 7955619 2028-08-12 Drug product 2017-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209777-003 10314788 2028-08-12 Drug product 2019-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209777-003 7955619 2028-08-12 Drug product 2017-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209777-004 10314788 2028-08-12 Drug product 2024-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209777-004 7955619 2028-08-12 Drug product 2024-10-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209777-001 10314788 2028-08-12 Drug product 2019-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209777-001 7955619 2028-08-12 Drug product 2017-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209777-002 10314788 2028-08-12 Drug product 2019-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209777-002 7955619 2028-08-12 Drug product 2017-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209777-003 10314788 2028-08-12 Drug product 2019-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209777-003 7955619 2028-08-12 Drug product 2017-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209777-004 10314788 2028-08-12 Drug product 2024-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209777-004 7955619 2028-08-12 Drug product 2024-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209777-001 10314788 2028-08-12 Drug product 2019-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209777-001 7955619 2028-08-12 Drug product 2017-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209777-002 10314788 2028-08-12 Drug product 2019-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209777-002 7955619 2028-08-12 Drug product 2017-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209777-003 10314788 2028-08-12 Drug product 2019-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209777-003 7955619 2028-08-12 Drug product 2017-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209777-004 10314788 2028-08-12 Drug product 2024-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209777-004 7955619 2028-08-12 Drug product 2024-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-001 10314788 2028-08-12 Drug product 2019-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-001 7955619 2028-08-12 Drug product 2017-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-002 10314788 2028-08-12 Drug product 2019-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-002 7955619 2028-08-12 Drug product 2017-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-003 10314788 2028-08-12 Drug product 2019-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-003 7955619 2028-08-12 Drug product 2017-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-004 10314788 2028-08-12 Drug product 2024-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209777-004 7955619 2028-08-12 Drug product 2024-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209777-001 10314788 2028-08-12 Drug product 2019-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209777-001 7955619 2028-08-12 Drug product 2017-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209777-002 10314788 2028-08-12 Drug product 2019-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209777-002 7955619 2028-08-12 Drug product 2017-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209777-003 10314788 2028-08-12 Drug product 2019-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209777-003 7955619 2028-08-12 Drug product 2017-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209777-004 10314788 2028-08-12 Drug product 2024-10-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209777-004 7955619 2028-08-12 Drug product 2024-10-04 6a471c1ec25d…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base RoxyBond
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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1944529 Internal RxNorm lookup 1944535 Internal RxNorm lookup 1944538 Internal RxNorm lookup 1944540 Internal RxNorm lookup 1944541 Internal RxNorm lookup 1944543 Internal RxNorm lookup 2693194 Internal RxNorm lookup 2693196 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 81140-103-10 RoxyBond 100 in 1 BOTTLE TABLET, COATED 100 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81140-103 ROXYBOND (OXYCODONE HYDROCHLORIDE) TABLET, COATED [PROTEGA PHARMACEUTICALS INC] 9 Current NDC, Legacy NDC, 1 package rows 20240915_72398542-8e0a-47b2-afeb-9ca5a1f15083.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RoxyBond OXYCODONE HYDROCHLORIDE Protega Pharmaceuticals Inc 72398542-8e0a-47b2-afeb-9ca5a1f15083 2026-01-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 209777 application number: NDA209777 ndc (product): 81140-103
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2693194 oxyCODONE hydrochloride 10 MG Oral Tablet, Abuse-Deterrent PSN 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944529 oxyCODONE hydrochloride 15 MG Oral Tablet, Abuse-Deterrent PSN 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944538 oxyCODONE hydrochloride 30 MG Oral Tablet, Abuse-Deterrent PSN 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944541 oxyCODONE hydrochloride 5 MG Oral Tablet, Abuse-Deterrent PSN 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 2693196 RoxyBond 10 MG Oral Tablet PSN 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944535 RoxyBond 15 MG Oral Tablet PSN 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944540 RoxyBond 30 MG Oral Tablet PSN 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944543 RoxyBond 5 MG Oral Tablet PSN 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 2693196 Abuse-Deterrent oxycodone hydrochloride 10 MG Oral Tablet [Roxybond] SBD 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944535 Abuse-Deterrent oxycodone hydrochloride 15 MG Oral Tablet [Roxybond] SBD 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944540 Abuse-Deterrent oxycodone hydrochloride 30 MG Oral Tablet [Roxybond] SBD 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944543 Abuse-Deterrent oxycodone hydrochloride 5 MG Oral Tablet [Roxybond] SBD 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 2693194 Abuse-Deterrent oxycodone hydrochloride 10 MG Oral Tablet SCD 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944529 Abuse-Deterrent oxycodone hydrochloride 15 MG Oral Tablet SCD 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944538 Abuse-Deterrent oxycodone hydrochloride 30 MG Oral Tablet SCD 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944541 Abuse-Deterrent oxycodone hydrochloride 5 MG Oral Tablet SCD 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 2693194 oxycodone hydrochloride 10 MG (equivalent to oxycodone 9 MG) Oral Tablet, Abuse-Deterrent SY 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944529 oxycodone hydrochloride 15 MG (equivalent to oxycodone 13.4 MG) Oral Tablet, Abuse-Deterrent SY 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944538 oxycodone hydrochloride 30 MG (equivalent to oxycodone 26.9 MG) Oral Tablet, Abuse-Deterrent SY 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944541 oxycodone hydrochloride 5 MG (equivalent to oxycodone 4.5 MG) Oral Tablet, Abuse-Deterrent SY 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 2693196 RoxyBond 10 MG Oral Tablet SY 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944535 RoxyBond 15 MG Oral Tablet SY 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944540 RoxyBond 30 MG Oral Tablet SY 72398542-8e0a-47b2-afeb-9ca5a1f15083 11 1944543 RoxyBond 5 MG Oral Tablet SY 72398542-8e0a-47b2-afeb-9ca5a1f15083 11
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 81140-103-10 81140010310 100 TABLET, COATED in 1 BOTTLE (81140-103-10) 2023-12-19 0000-00-00 No No Current