Zohydro

Product NDC: 43376-350
11-digit product format: 433760350
Labeler code: 43376
Product ID: 43376-350_5acca313-4e09-4063-83f3-49ffc4d6fe76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocodone bitartrate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Zogenix, Inc.
Application: NDA202880
Marketing category: NDA
Marketing start: 2013-10-25
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE
Active strength: 50 mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43376-350		I	Inactivated by FDA		2026-08-10
excluded package	package	43376-350	43376-350-60	I	Inactivated by FDA		2026-08-10

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43376-350-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43376-350-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43376-350-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43376-350-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43376-350-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43376-350-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43376-350-60	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43376-350-60	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43376-350-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43376-350-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43376-350-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43376-350-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43376-350-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43376-350-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43376-350-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43376-350-60	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43376-350-60	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43376-350-60	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43376-350-60	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43376-350-60	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43376-350-60	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	43376-350-60	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
7855f8e3-562e-4273-8b79-0059c07a71f7	Product name	1	20170901
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
b654f2d9-ebeb-451d-96ee-22f583344623	Product name	1	20170424
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43376-350-60	2020-01-31	C162847	48780-1	9d75b9cf-f080-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ZOHYDRO ® ER safely and effectively. See full prescribing information for ZOHYDRO ® ER. ZOHYDRO ® ER (hydrocodone bitartrate) extended‑release capsules, for oral use, CII Initial U.S. Approval: 1943

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43376-350-60	Zohydro	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43376-350-60	EA - Each	43376-350	c7b4adbd-dd4e-42b8-886d-a49f4eb888f5	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43376-350	ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]	20	Legacy NDC, 1 package rows	20150227_6ccfbd98-7750-4955-a654-ec104fb666f9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1860491	HYDROcodone bitartrate 10 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860493	HYDROcodone bitartrate 15 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860495	HYDROcodone bitartrate 20 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860497	HYDROcodone bitartrate 30 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860499	HYDROcodone bitartrate 40 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860501	HYDROcodone bitartrate 50 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860492	Zohydro ER 10 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860494	Zohydro ER 15 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860496	Zohydro ER 20 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860498	Zohydro ER 30 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860500	Zohydro ER 40 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860502	Zohydro ER 50 MG 12HR Extended Release Oral Capsule	PSN	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860492	12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule [Zohydro]	SBD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860494	12 HR hydrocodone bitartrate 15 MG Extended Release Oral Capsule [Zohydro]	SBD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860496	12 HR hydrocodone bitartrate 20 MG Extended Release Oral Capsule [Zohydro]	SBD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860498	12 HR hydrocodone bitartrate 30 MG Extended Release Oral Capsule [Zohydro]	SBD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860500	12 HR hydrocodone bitartrate 40 MG Extended Release Oral Capsule [Zohydro]	SBD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860502	12 HR hydrocodone bitartrate 50 MG Extended Release Oral Capsule [Zohydro]	SBD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860491	12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule	SCD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860493	12 HR hydrocodone bitartrate 15 MG Extended Release Oral Capsule	SCD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860495	12 HR hydrocodone bitartrate 20 MG Extended Release Oral Capsule	SCD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860497	12 HR hydrocodone bitartrate 30 MG Extended Release Oral Capsule	SCD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860499	12 HR hydrocodone bitartrate 40 MG Extended Release Oral Capsule	SCD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860501	12 HR hydrocodone bitartrate 50 MG Extended Release Oral Capsule	SCD	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860492	12 HR Zohydro 10 MG Extended Release Oral Capsule	SY	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860494	12 HR Zohydro 15 MG Extended Release Oral Capsule	SY	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860496	12 HR Zohydro 20 MG Extended Release Oral Capsule	SY	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860498	12 HR Zohydro 30 MG Extended Release Oral Capsule	SY	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860500	12 HR Zohydro 40 MG Extended Release Oral Capsule	SY	6ccfbd98-7750-4955-a654-ec104fb666f9	20
1860502	12 HR Zohydro 50 MG Extended Release Oral Capsule	SY	6ccfbd98-7750-4955-a654-ec104fb666f9	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43376-350-60	43376035060	60 in 1 BOTTLE	Historical