RoxyBond

Product NDC: 81140-104
Requested package NDC: 81140-104-10
11-digit product format: 811400104
Labeler code: 81140
Product ID: 81140-104_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: 10 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	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	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	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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209777-001	NP	2020-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209777-002	NP	2020-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209777-003	NP	2020-04-20	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N209777-001	NP	2020-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209777-002	NP	2020-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209777-003	NP	2020-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209777-001	NP	2020-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209777-002	NP	2020-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209777-003	NP	2020-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209777-001	NP	2020-04-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209777-002	NP	2020-04-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209777-003	NP	2020-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209777-001	NP	2020-04-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209777-002	NP	2020-04-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209777-003	NP	2020-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209777-001	NP	2020-04-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209777-002	NP	2020-04-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209777-003	NP	2020-04-20	`ea99ee380514…`

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	10 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
72398542-8e0a-47b2-afeb-9ca5a1f15083	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
b8cd3792-f010-440e-ac63-7713119fde04	Product name	9	20220110
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3	Product name	9	20190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556	Product name	6	20170913
5da64f4c-1e90-423d-af7a-5a52bb3e823e	Product name	4	20170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6	Product name	1	20170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778	Product name	1	20161103
68d3ff71-7803-4cf4-ba84-71ce4712df22	Product name	1	20160620
07e5b999-fda7-79c9-8f77-8380537ade79	Product name	4	20160517
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7fa873c5-fb27-7119-0a05-634ad477dea7	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
f46484d2-0de6-24f4-bf73-a8f2af6723ef	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81140-104-10	RoxyBond	100 in 1 BOTTLE	TABLET, COATED	100		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81140-104-10	EA - Each	81140-104	4222e454-5dee-41d8-807b-f50366bceeeb	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81140-104	ROXYBOND (OXYCODONE HYDROCHLORIDE) TABLET, COATED [PROTEGA PHARMACEUTICALS INC]	9	Current 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 (package): 81140-104-10 ndc (product): 81140-104 ndc11 (package): 81140010410

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE

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	Sample	Exclude flag	Status
81140-104-10	81140010410	100 TABLET, COATED in 1 BOTTLE (81140-104-10)	2023-12-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RoxyBond	Protega Pharmaceuticals Inc \| Galephar Pharmaceutical Research Inc	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	11