XTAMPZA

Product NDC: 24510-115
11-digit product format: 245100115
Labeler code: 24510
Product ID: 24510-115_fda0989d-9319-4e35-af83-fca1ec66878e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYCODONE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Collegium Pharmaceutical, Inc.
Application: NDA208090
Marketing category: NDA
Marketing start: 2016-05-10
Substance: OXYCODONE
Active strength: 13.5 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 1.

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	RLD / RS	Approval date
N208090-001	XTAMPZA ER	OXYCODONE	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26
N208090-002	XTAMPZA ER	OXYCODONE	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26
N208090-003	XTAMPZA ER	OXYCODONE	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26
N208090-004	XTAMPZA ER	OXYCODONE	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26
N208090-005	XTAMPZA ER	OXYCODONE	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26

Orange Book patents#

Current patent rows page 1 of 1 · 40 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208090-001	7771707	2028-10-09		Drug product	2016-07-19
N208090-001	10004729	2030-12-10	U-1556	Drug product	2018-07-10
N208090-001	10668060	2030-12-10	U-1556	Drug product	2020-06-03
N208090-001	9682075	2030-12-10	U-1556	Drug product	2017-06-20
N208090-001	10188644	2036-09-02	U-1556	Drug product	2019-01-29
N208090-001	10646485	2036-09-02	U-1556	Drug product	2020-05-13
N208090-001	9737530	2036-09-02	U-1556	Drug product	2017-08-23
N208090-001	9968598	2036-09-02	U-1556	Drug product	2018-05-16
N208090-002	7771707	2028-10-09		Drug product	2016-07-19
N208090-002	10004729	2030-12-10	U-1556	Drug product	2018-07-10
N208090-002	10668060	2030-12-10	U-1556	Drug product	2020-06-03
N208090-002	9682075	2030-12-10	U-1556	Drug product	2017-06-20
N208090-002	10188644	2036-09-02	U-1556	Drug product	2019-01-29
N208090-002	10646485	2036-09-02	U-1556	Drug product	2020-05-13
N208090-002	9737530	2036-09-02	U-1556	Drug product	2017-08-23
N208090-002	9968598	2036-09-02	U-1556	Drug product	2018-05-16
N208090-003	7771707	2028-10-09		Drug product	2016-07-19
N208090-003	10004729	2030-12-10	U-1556	Drug product	2018-07-10
N208090-003	10668060	2030-12-10	U-1556	Drug product	2020-06-03
N208090-003	9682075	2030-12-10	U-1556	Drug product	2017-06-20
N208090-003	10188644	2036-09-02	U-1556	Drug product	2019-01-29
N208090-003	10646485	2036-09-02	U-1556	Drug product	2020-05-13
N208090-003	9737530	2036-09-02	U-1556	Drug product	2017-08-23
N208090-003	9968598	2036-09-02	U-1556	Drug product	2018-05-16
N208090-004	7771707	2028-10-09		Drug product	2016-07-19
N208090-004	10004729	2030-12-10	U-1556	Drug product	2018-07-10
N208090-004	10668060	2030-12-10	U-1556	Drug product	2020-06-03
N208090-004	9682075	2030-12-10	U-1556	Drug product	2017-06-20
N208090-004	10188644	2036-09-02	U-1556	Drug product	2019-01-29
N208090-004	10646485	2036-09-02	U-1556	Drug product	2020-05-13
N208090-004	9737530	2036-09-02	U-1556	Drug product	2017-08-23
N208090-004	9968598	2036-09-02	U-1556	Drug product	2018-05-16
N208090-005	7771707	2028-10-09		Drug product	2016-07-19
N208090-005	10004729	2030-12-10	U-1556	Drug product	2018-07-10
N208090-005	10668060	2030-12-10	U-1556	Drug product	2020-06-03
N208090-005	9682075	2030-12-10	U-1556	Drug product	2017-06-20
N208090-005	10188644	2036-09-02	U-1556	Drug product	2019-01-29
N208090-005	10646485	2036-09-02	U-1556	Drug product	2020-05-13
N208090-005	9737530	2036-09-02	U-1556	Drug product	2017-08-23
N208090-005	9968598	2036-09-02	U-1556	Drug product	2018-05-16

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 80 · 3,180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208090-001	7771707	2028-10-09		Drug product	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	10004729	2030-12-10	U-1556	Drug product	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	10668060	2030-12-10	U-1556	Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	9682075	2030-12-10	U-1556	Drug product	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	10188644	2036-09-02	U-1556	Drug product	2019-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	10646485	2036-09-02	U-1556	Drug product	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	9737530	2036-09-02	U-1556	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	9968598	2036-09-02	U-1556	Drug product	2018-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	7771707	2028-10-09		Drug product	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	10004729	2030-12-10	U-1556	Drug product	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	10668060	2030-12-10	U-1556	Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	9682075	2030-12-10	U-1556	Drug product	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	10188644	2036-09-02	U-1556	Drug product	2019-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	10646485	2036-09-02	U-1556	Drug product	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	9737530	2036-09-02	U-1556	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	9968598	2036-09-02	U-1556	Drug product	2018-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	7771707	2028-10-09		Drug product	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	10004729	2030-12-10	U-1556	Drug product	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	10668060	2030-12-10	U-1556	Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	9682075	2030-12-10	U-1556	Drug product	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	10188644	2036-09-02	U-1556	Drug product	2019-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	10646485	2036-09-02	U-1556	Drug product	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	9737530	2036-09-02	U-1556	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	9968598	2036-09-02	U-1556	Drug product	2018-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	7771707	2028-10-09		Drug product	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	10004729	2030-12-10	U-1556	Drug product	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	10668060	2030-12-10	U-1556	Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	9682075	2030-12-10	U-1556	Drug product	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	10188644	2036-09-02	U-1556	Drug product	2019-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	10646485	2036-09-02	U-1556	Drug product	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	9737530	2036-09-02	U-1556	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	9968598	2036-09-02	U-1556	Drug product	2018-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	7771707	2028-10-09		Drug product	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	10004729	2030-12-10	U-1556	Drug product	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	10668060	2030-12-10	U-1556	Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	9682075	2030-12-10	U-1556	Drug product	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	10188644	2036-09-02	U-1556	Drug product	2019-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	10646485	2036-09-02	U-1556	Drug product	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	9737530	2036-09-02	U-1556	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	9968598	2036-09-02	U-1556	Drug product	2018-05-16	`011fe1cb6892…`

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	N208090-001	NP	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208090-002	NP	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208090-003	NP	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208090-004	NP	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208090-005	NP	2019-04-26	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208090-001	NP	2019-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208090-002	NP	2019-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208090-003	NP	2019-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208090-004	NP	2019-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208090-005	NP	2019-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208090-001	NP	2019-04-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208090-002	NP	2019-04-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208090-003	NP	2019-04-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208090-004	NP	2019-04-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208090-005	NP	2019-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208090-001	NP	2019-04-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208090-002	NP	2019-04-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208090-003	NP	2019-04-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208090-004	NP	2019-04-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208090-005	NP	2019-04-26	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: XTAMPZA
Brand name suffix: ER
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE	13.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CD35PMG570	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1790527	Internal RxNorm lookup
1790533	Internal RxNorm lookup
1791558	Internal RxNorm lookup
1791560	Internal RxNorm lookup
1791567	Internal RxNorm lookup
1791569	Internal RxNorm lookup
1791574	Internal RxNorm lookup
1791576	Internal RxNorm lookup
1791580	Internal RxNorm lookup
1791582	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
b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	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
24510-115-10	XTAMPZA ER	100 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	100		11
24510-115-20	XTAMPZA ER	20 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	20		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24510-115-10	EA - Each	24510-115	660702b5-e50f-48d1-af78-f551e5c37ea7	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24510-115	XTAMPZA ER (OXYCODONE) CAPSULE, EXTENDED RELEASE [COLLEGIUM PHARMACEUTICAL, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20231223_b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c.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
XTAMPZA ER	OXYCODONE	Collegium Pharmaceutical, Inc.	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208090 application number: NDA208090 ndc (product): 24510-115

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CD35PMG570	OXYCODONE	76-42-6	OXYCODONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1791558	oxyCODONE 13.5 MG 12HR Extended Release Oral Capsule, Abuse-Deterrent	PSN	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791567	oxyCODONE 18 MG 12HR Extended Release Oral Capsule, Abuse-Deterrent	PSN	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791574	oxyCODONE 27 MG 12HR Extended Release Oral Capsule, Abuse-Deterrent	PSN	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791580	oxyCODONE 36 MG 12HR Extended Release Oral Capsule, Abuse-Deterrent	PSN	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1790527	oxyCODONE 9 MG 12HR Extended Release Oral Capsule, Abuse-Deterrent	PSN	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791560	Xtampza ER 13.5 MG 12HR Extended Release Oral Capsule	PSN	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791569	Xtampza ER 18 MG 12HR Extended Release Oral Capsule	PSN	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791576	Xtampza ER 27 MG 12HR Extended Release Oral Capsule	PSN	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791582	Xtampza ER 36 MG 12HR Extended Release Oral Capsule	PSN	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1790533	Xtampza ER 9 MG 12HR Extended Release Oral Capsule	PSN	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791560	Abuse-Deterrent 12 HR oxycodone 13.5 MG Extended Release Oral Capsule [Xtampza]	SBD	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791569	Abuse-Deterrent 12 HR oxycodone 18 MG Extended Release Oral Capsule [Xtampza]	SBD	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791576	Abuse-Deterrent 12 HR oxycodone 27 MG Extended Release Oral Capsule [Xtampza]	SBD	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791582	Abuse-Deterrent 12 HR oxycodone 36 MG Extended Release Oral Capsule [Xtampza]	SBD	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1790533	Abuse-Deterrent 12 HR oxycodone 9 MG Extended Release Oral Capsule [Xtampza]	SBD	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791558	Abuse-Deterrent 12 HR oxycodone 13.5 MG Extended Release Oral Capsule	SCD	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791567	Abuse-Deterrent 12 HR oxycodone 18 MG Extended Release Oral Capsule	SCD	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791574	Abuse-Deterrent 12 HR oxycodone 27 MG Extended Release Oral Capsule	SCD	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791580	Abuse-Deterrent 12 HR oxycodone 36 MG Extended Release Oral Capsule	SCD	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1790527	Abuse-Deterrent 12 HR oxycodone 9 MG Extended Release Oral Capsule	SCD	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791558	oxycodone 13.5 MG (equivalent to 15 MG oxycodone HCl) 12 HR Extended Release Oral Capsule, Abuse-Deterrent	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791558	oxycodone 13.5 MG 12 HR Extended Release Oral Capsule, Abuse-Deterrent	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791567	oxycodone 18 MG (equivalent to 20 MG oxycodone HCl) 12 HR Extended Release Oral Capsule, Abuse-Deterrent	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791567	oxyCODONE 18 MG 12 HR Extended Release Oral Capsule, Abuse-Deterrent	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791574	oxycodone 27 MG (equivalent to 30 MG oxycodone HCl) 12 HR Extended Release Oral Capsule, Abuse-Deterrent	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791574	oxycodone 27 MG 12 HR Extended Release Oral Capsule, Abuse-Deterrent	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791580	oxycodone 36 MG (equivalent to 40 MG oxycodone HCl) 12 HR Extended Release Oral Capsule, Abuse-Deterrent	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791580	oxycodone 36 MG 12 HR Extended Release Oral Capsule, Abuse-Deterrent	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1790527	oxycodone 9 MG (equivalent to 10 MG oxycodone HCl) 12 HR Extended Release Oral Capsule 12 HR Extended Release Oral Capsule, Abuse-Deterrent	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1790527	oxycodone 9 MG 12 HR Extended Release Oral Capsule, Abuse-Deterrent	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791560	Xtampza ER 13.5 MG (equivalent to 15 MG oxycodone HCl) 12 HR Extended Release Oral Capsule	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791560	Xtampza ER 13.5 MG 12 HR Extended Release Oral Capsule	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791569	Xtampza ER 18 MG (equivalent to 20 MG oxycodone HCl) 12 HR Extended Release Oral Capsule	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791569	Xtampza ER 18 MG 12 HR Extended Release Oral Capsule	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791576	Xtampza ER 27 MG (equivalent to oxycodone hydrochloride 30 MG) 12 HR Extended Release Oral Capsule	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791576	Xtampza ER 27 MG 12 HR Extended Release Oral Capsule	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791582	Xtampza ER 36 MG (equivalent to 40 MG oxycodone HCl) 12 HR Extended Release Oral Capsule	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1791582	Xtampza ER 36 MG 12 HR Extended Release Oral Capsule	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1790533	Xtampza ER 9 MG (equivalent to 10 MG oxycodone HCl) 12 HR Extended Release Oral Capsule	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11
1790533	Xtampza ER 9 MG 12 HR Extended Release Oral Capsule	SY	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24510-115-10	24510011510	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-115-10)	2016-05-10	0000-00-00	No	No	Current
24510-115-20	24510011520	20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-115-20)	2016-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XTAMPZA ER	Collegium Pharmaceutical, Inc. \| Patheon Pharmaceuticals, Inc	2025-12-30	HUMAN PRESCRIPTION DRUG LABEL	11