Application 202880

Type: NDA
Sponsor: PERSION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	Yes
002	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	Yes	No
003	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
004	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No
005	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	No
006	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N202880-001	ZOHYDRO ER	HYDROCODONE BITARTRATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25
N202880-002	ZOHYDRO ER	HYDROCODONE BITARTRATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25
N202880-003	ZOHYDRO ER	HYDROCODONE BITARTRATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25
N202880-004	ZOHYDRO ER	HYDROCODONE BITARTRATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25
N202880-005	ZOHYDRO ER	HYDROCODONE BITARTRATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25
N202880-006	ZOHYDRO ER	HYDROCODONE BITARTRATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25

Orange Book patents#

Current patent rows page 1 of 2 · 96 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202880-001	10028946	2033-07-25	U-1810		2018-07-27
N202880-001	10322120	2033-07-25		Drug product	2019-07-17
N202880-001	10456393	2033-07-25	U-1810		2019-10-29
N202880-001	10722511	2033-07-25	U-1810		2020-08-25
N202880-001	9265760	2033-07-25	U-1810		2016-02-23
N202880-001	9326982	2033-07-25	U-1810		2016-05-04
N202880-001	9333201	2033-07-25	U-1810		2016-05-18
N202880-001	9339499	2033-07-25	U-1810		2016-05-18
N202880-001	9421200	2033-07-25	U-1810		2016-09-07
N202880-001	9433619	2033-07-25	U-1810		2016-09-07
N202880-001	9610286	2033-07-25	U-1810		2017-04-05
N202880-001	10092559	2034-09-12	U-55		2018-11-13
N202880-001	9132096	2034-09-12		Drug product	2015-09-22
N202880-001	9452163	2034-09-12	U-55		2016-10-11
N202880-001	9486451	2034-09-12	U-55		2017-01-12
N202880-001	9713611	2034-09-12	U-55	Drug product	2017-08-23
N202880-002	10028946	2033-07-25	U-1810		2018-07-27
N202880-002	10322120	2033-07-25		Drug product	2019-07-17
N202880-002	10456393	2033-07-25	U-1810		2019-10-29
N202880-002	10722511	2033-07-25	U-1810		2020-08-25
N202880-002	9265760	2033-07-25	U-1810		2016-02-23
N202880-002	9326982	2033-07-25	U-1810		2016-05-04
N202880-002	9333201	2033-07-25	U-1810		2016-05-18
N202880-002	9339499	2033-07-25	U-1810		2016-05-18
N202880-002	9421200	2033-07-25	U-1810		2016-09-07
N202880-002	9433619	2033-07-25	U-1810		2016-09-07
N202880-002	9610286	2033-07-25	U-1810		2017-04-05
N202880-002	10092559	2034-09-12	U-55		2018-11-13
N202880-002	9132096	2034-09-12		Drug product	2015-09-22
N202880-002	9452163	2034-09-12	U-55		2016-10-11
N202880-002	9486451	2034-09-12	U-55		2017-01-12
N202880-002	9713611	2034-09-12	U-55	Drug product	2017-08-23
N202880-003	10028946	2033-07-25	U-1810		2018-07-27
N202880-003	10322120	2033-07-25		Drug product	2019-07-17
N202880-003	10456393	2033-07-25	U-1810		2019-10-29
N202880-003	10722511	2033-07-25	U-1810		2020-08-25
N202880-003	9265760	2033-07-25	U-1810		2016-02-23
N202880-003	9326982	2033-07-25	U-1810		2016-05-04
N202880-003	9333201	2033-07-25	U-1810		2016-05-18
N202880-003	9339499	2033-07-25	U-1810		2016-05-18
N202880-003	9421200	2033-07-25	U-1810		2016-09-07
N202880-003	9433619	2033-07-25	U-1810		2016-09-07
N202880-003	9610286	2033-07-25	U-1810		2017-04-05
N202880-003	10092559	2034-09-12	U-55		2018-11-13
N202880-003	9132096	2034-09-12		Drug product	2015-09-22
N202880-003	9452163	2034-09-12	U-55		2016-10-11
N202880-003	9486451	2034-09-12	U-55		2017-01-12
N202880-003	9713611	2034-09-12	U-55	Drug product	2017-08-23
N202880-004	10028946	2033-07-25	U-1810		2018-07-27
N202880-004	10322120	2033-07-25		Drug product	2019-07-17
N202880-004	10456393	2033-07-25	U-1810		2019-10-29
N202880-004	10722511	2033-07-25	U-1810		2020-08-25
N202880-004	9265760	2033-07-25	U-1810		2016-02-23
N202880-004	9326982	2033-07-25	U-1810		2016-05-04
N202880-004	9333201	2033-07-25	U-1810		2016-05-18
N202880-004	9339499	2033-07-25	U-1810		2016-05-18
N202880-004	9421200	2033-07-25	U-1810		2016-09-07
N202880-004	9433619	2033-07-25	U-1810		2016-09-07
N202880-004	9610286	2033-07-25	U-1810		2017-04-05
N202880-004	10092559	2034-09-12	U-55		2018-11-13
N202880-004	9132096	2034-09-12		Drug product	2015-09-22
N202880-004	9452163	2034-09-12	U-55		2016-10-11
N202880-004	9486451	2034-09-12	U-55		2017-01-12
N202880-004	9713611	2034-09-12	U-55	Drug product	2017-08-23
N202880-005	10028946	2033-07-25	U-1810		2018-07-27
N202880-005	10322120	2033-07-25		Drug product	2019-07-17
N202880-005	10456393	2033-07-25	U-1810		2019-10-29
N202880-005	10722511	2033-07-25	U-1810		2020-08-25
N202880-005	9265760	2033-07-25	U-1810		2016-02-23
N202880-005	9326982	2033-07-25	U-1810		2016-05-04
N202880-005	9333201	2033-07-25	U-1810		2016-05-18
N202880-005	9339499	2033-07-25	U-1810		2016-05-18
N202880-005	9421200	2033-07-25	U-1810		2016-09-07
N202880-005	9433619	2033-07-25	U-1810		2016-09-07
N202880-005	9610286	2033-07-25	U-1810		2017-04-05
N202880-005	10092559	2034-09-12	U-55		2018-11-13
N202880-005	9132096	2034-09-12		Drug product	2015-09-22
N202880-005	9452163	2034-09-12	U-55		2016-10-11
N202880-005	9486451	2034-09-12	U-55		2017-01-12
N202880-005	9713611	2034-09-12	U-55	Drug product	2017-08-23

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 7 · 246 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	N202880-001	ZOHYDRO ER	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	ZOHYDRO ER	15MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-003	ZOHYDRO ER	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-004	ZOHYDRO ER	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-005	ZOHYDRO ER	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-006	ZOHYDRO ER	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202880-001	ZOHYDRO ER	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202880-002	ZOHYDRO ER	15MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202880-003	ZOHYDRO ER	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202880-004	ZOHYDRO ER	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202880-005	ZOHYDRO ER	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202880-006	ZOHYDRO ER	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202880-001	ZOHYDRO ER	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202880-002	ZOHYDRO ER	15MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202880-003	ZOHYDRO ER	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202880-004	ZOHYDRO ER	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202880-005	ZOHYDRO ER	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202880-006	ZOHYDRO ER	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202880-001	ZOHYDRO ER	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202880-002	ZOHYDRO ER	15MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202880-003	ZOHYDRO ER	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202880-004	ZOHYDRO ER	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202880-005	ZOHYDRO ER	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202880-006	ZOHYDRO ER	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202880-001	ZOHYDRO ER	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202880-002	ZOHYDRO ER	15MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202880-003	ZOHYDRO ER	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202880-004	ZOHYDRO ER	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202880-005	ZOHYDRO ER	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202880-006	ZOHYDRO ER	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202880-001	ZOHYDRO ER	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202880-002	ZOHYDRO ER	15MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202880-003	ZOHYDRO ER	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202880-004	ZOHYDRO ER	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202880-005	ZOHYDRO ER	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202880-006	ZOHYDRO ER	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202880-001	ZOHYDRO ER	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202880-002	ZOHYDRO ER	15MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202880-003	ZOHYDRO ER	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202880-004	ZOHYDRO ER	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2013-10-25	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202880-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202880-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202880-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202880-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202880-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202880-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202880-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202880-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202880-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202880-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202880-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202880-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202880-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202880-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202880-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202880-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202880-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202880-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202880-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202880-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202880-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202880-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202880-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202880-006	AB	1	`c0c555d07b60…`

Observed Orange Book patent history#

Patent history page 1 of 99 · 3,942 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	N202880-001	10028946	2033-07-25	U-1810		2018-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	10322120	2033-07-25		Drug product	2019-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	10456393	2033-07-25	U-1810		2019-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	10722511	2033-07-25	U-1810		2020-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9265760	2033-07-25	U-1810		2016-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9326982	2033-07-25	U-1810		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9333201	2033-07-25	U-1810		2016-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9339499	2033-07-25	U-1810		2016-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9421200	2033-07-25	U-1810		2016-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9433619	2033-07-25	U-1810		2016-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9610286	2033-07-25	U-1810		2017-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	10092559	2034-09-12	U-55		2018-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9132096	2034-09-12		Drug product	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9452163	2034-09-12	U-55		2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9486451	2034-09-12	U-55		2017-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-001	9713611	2034-09-12	U-55	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	10028946	2033-07-25	U-1810		2018-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	10322120	2033-07-25		Drug product	2019-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	10456393	2033-07-25	U-1810		2019-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	10722511	2033-07-25	U-1810		2020-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9265760	2033-07-25	U-1810		2016-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9326982	2033-07-25	U-1810		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9333201	2033-07-25	U-1810		2016-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9339499	2033-07-25	U-1810		2016-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9421200	2033-07-25	U-1810		2016-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9433619	2033-07-25	U-1810		2016-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9610286	2033-07-25	U-1810		2017-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	10092559	2034-09-12	U-55		2018-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9132096	2034-09-12		Drug product	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9452163	2034-09-12	U-55		2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9486451	2034-09-12	U-55		2017-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-002	9713611	2034-09-12	U-55	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-003	10028946	2033-07-25	U-1810		2018-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-003	10322120	2033-07-25		Drug product	2019-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-003	10456393	2033-07-25	U-1810		2019-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-003	10722511	2033-07-25	U-1810		2020-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-003	9265760	2033-07-25	U-1810		2016-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-003	9326982	2033-07-25	U-1810		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-003	9333201	2033-07-25	U-1810		2016-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202880-003	9339499	2033-07-25	U-1810		2016-05-18	`011fe1cb6892…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hysingla ER	HYDROCODONE BITARTRATE	Knoa Pharma LLC	b7d23ac2-e776-9f62-3290-c64c2d6eb353	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROCODONE BITARTRATE
Hydrocodone Bitartrate	HYDROCODONE BITARTRATE	Alvogen Inc.	f7b55d14-0980-b680-8ceb-7489ff65455e	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROCODONE BITARTRATE
Hydrocodone Bitartrate	HYDROCODONE BITARTRATE	Alvogen Inc.	a7b8ea07-e926-f0a5-c20d-92f23ed350d0	2023-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROCODONE BITARTRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43376-210	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-215	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-220	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-230	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-240	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-250	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-310	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-315	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-320	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-330	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-340	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-350	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
65224-310	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-310	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-310	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-310	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-310	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-315	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-315	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-315	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-315	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-315	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-320	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-320	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-320	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-320	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-320	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-330	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-330	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-330	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-330	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-330	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-340	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-340	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-340	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-340	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-340	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-350	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-350	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-350	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-350	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-350	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-910	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65224-915	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65224-920	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65224-930	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65224-940	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65224-950	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66647	SUPPL	2021-03-08
66646	SUPPL	2021-03-08
66578	SUPPL	2021-03-08
60419	SUPPL	2019-10-09
60418	SUPPL	2019-10-09
60377	SUPPL	2019-10-08
55722	SUPPL	2018-10-01
55721	SUPPL	2018-10-01
55559	SUPPL	2018-09-21
55558	SUPPL	2018-09-21
48585	SUPPL	2017-05-31
46442	SUPPL	2016-12-21
46441	SUPPL	2016-12-21
46321	SUPPL	2016-12-20
46320	SUPPL	2016-12-20
45449	SUPPL	2016-10-03
10127	SUPPL	2016-04-22
32331	SUPPL	2015-07-07
40232	SUPPL	2015-02-17
44871	SUPPL	2015-02-06
32330	SUPPL	2015-02-05
32329	SUPPL	2014-08-20
19395	SUPPL	2014-08-20
43417	ORIG	2014-04-14
24108	ORIG	2014-04-01
44870	ORIG	2013-11-15
19394	ORIG	2013-10-25
10126	ORIG	2013-10-25