BYDUREON

Product NDC: 0310-6530
Requested package NDC: 0310-6530-01
11-digit product format: 003106530
Labeler code: 0310
Product ID: 0310-6530_c9d94096-3a71-4708-97e1-ae0b9a31c681
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: exenatide
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: SUBCUTANEOUS
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA022200
Marketing category: NDA
Marketing start: 2014-09-08
Marketing end: 2023-04-30
Substance: EXENATIDE
Active strength: 2 mg/.65mL
Pharmacologic classes: GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0310-6530	0310-6530-01	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 8 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-6530	0310-6530-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-6530	0310-6530-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-6530	0310-6530-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-6530	0310-6530-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-6530	0310-6530-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-6530	0310-6530-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-6530	0310-6530-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-6530	0310-6530-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022200-001	BYDUREON	EXENATIDE SYNTHETIC	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2012-01-27
N022200-002	BYDUREON PEN	EXENATIDE SYNTHETIC	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2014-02-28

Orange Book patents#

Current patent rows page 1 of 1 · 72 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022200-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2017-11-17
N022200-001	6515117*PED	2026-04-04		Pediatric extension
N022200-001	8329648	2026-08-18	U-2588		2013-01-10
N022200-001	8329648	2026-08-18	U-2589		2013-01-10
N022200-001	8329648	2026-08-18	U-2590		2013-01-10
N022200-001	8329648	2026-08-18	U-2593		2013-01-10
N022200-001	8329648	2026-08-18	U-2594		2013-01-10
N022200-001	8329648	2026-08-18	U-2595		2013-01-10
N022200-001	8329648	2026-08-18	U-2596		2013-01-10
N022200-001	8329648	2026-08-18	U-3188		2013-01-10
N022200-001	8329648	2026-08-18	U-3189		2013-01-10
N022200-001	8329648	2026-08-18	U-3190		2013-01-10
N022200-001	8906851	2026-08-18	U-2588		2015-01-06
N022200-001	8906851	2026-08-18	U-2589		2015-01-06
N022200-001	8906851	2026-08-18	U-2590		2015-01-06
N022200-001	8906851	2026-08-18	U-2593		2015-01-06
N022200-001	8906851	2026-08-18	U-3188		2015-01-06
N022200-001	8906851	2026-08-18	U-3189		2015-01-06
N022200-001	8906851	2026-08-18	U-3190		2015-01-06
N022200-001	9884092	2026-08-18	U-2588		2018-03-06
N022200-001	9884092	2026-08-18	U-2589		2018-03-06
N022200-001	9884092	2026-08-18	U-2590		2018-03-06
N022200-001	9884092	2026-08-18	U-2593		2018-03-06
N022200-001	9884092	2026-08-18	U-2594		2018-03-06
N022200-001	9884092	2026-08-18	U-2595		2018-03-06
N022200-001	9884092	2026-08-18	U-2596		2018-03-06
N022200-001	9884092	2026-08-18	U-3188		2018-03-06
N022200-001	9884092	2026-08-18	U-3189		2018-03-06
N022200-001	9884092	2026-08-18	U-3190		2018-03-06
N022200-001	8329648*PED	2027-02-18		Pediatric extension
N022200-001	8906851*PED	2027-02-18		Pediatric extension
N022200-001	9884092*PED	2027-02-18		Pediatric extension
N022200-001	8501698	2027-06-20	U-2588	Drug product	2017-11-17
N022200-001	8501698*PED	2027-12-20		Pediatric extension
N022200-001	8361972	2028-03-21	U-2588		2017-11-17
N022200-001	8361972*PED	2028-09-21		Pediatric extension
N022200-002	6515117	2025-10-04	U-2588	Drug substance, Drug product	2017-11-15
N022200-002	6515117*PED	2026-04-04		Pediatric extension
N022200-002	8329648	2026-08-18	U-2588		2014-03-28
N022200-002	8329648	2026-08-18	U-2589		2014-03-28
N022200-002	8329648	2026-08-18	U-2590		2014-03-28
N022200-002	8329648	2026-08-18	U-2593		2014-03-28
N022200-002	8329648	2026-08-18	U-2594		2014-03-28
N022200-002	8329648	2026-08-18	U-2595		2014-03-28
N022200-002	8329648	2026-08-18	U-2596		2014-03-28
N022200-002	8329648	2026-08-18	U-3188		2014-03-28
N022200-002	8329648	2026-08-18	U-3189		2014-03-28
N022200-002	8329648	2026-08-18	U-3190		2014-03-28
N022200-002	8906851	2026-08-18	U-2588		2015-01-06
N022200-002	8906851	2026-08-18	U-2589		2015-01-06
N022200-002	8906851	2026-08-18	U-2590		2015-01-06
N022200-002	8906851	2026-08-18	U-2593		2015-01-06
N022200-002	8906851	2026-08-18	U-3188		2015-01-06
N022200-002	8906851	2026-08-18	U-3189		2015-01-06
N022200-002	8906851	2026-08-18	U-3190		2015-01-06
N022200-002	9884092	2026-08-18	U-2588		2018-03-06
N022200-002	9884092	2026-08-18	U-2589		2018-03-06
N022200-002	9884092	2026-08-18	U-2590		2018-03-06
N022200-002	9884092	2026-08-18	U-2593		2018-03-06
N022200-002	9884092	2026-08-18	U-2594		2018-03-06
N022200-002	9884092	2026-08-18	U-2595		2018-03-06
N022200-002	9884092	2026-08-18	U-2596		2018-03-06
N022200-002	9884092	2026-08-18	U-3188		2018-03-06
N022200-002	9884092	2026-08-18	U-3189		2018-03-06
N022200-002	9884092	2026-08-18	U-3190		2018-03-06
N022200-002	8329648*PED	2027-02-18		Pediatric extension
N022200-002	8906851*PED	2027-02-18		Pediatric extension
N022200-002	9884092*PED	2027-02-18		Pediatric extension
N022200-002	8501698	2027-06-20	U-2588	Drug product	2017-11-15
N022200-002	8501698*PED	2027-12-20		Pediatric extension
N022200-002	8361972	2028-03-21	U-2588		2017-11-15
N022200-002	8361972*PED	2028-09-21		Pediatric extension

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 3 · 82 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	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2012-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2014-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2012-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2014-02-28	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 149 · 5,952 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	N022200-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2017-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	6515117*PED	2026-04-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648	2026-08-18	U-2590		2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648	2026-08-18	U-2589		2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648	2026-08-18	U-2595		2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648	2026-08-18	U-2593		2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648	2026-08-18	U-2596		2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648	2026-08-18	U-2588		2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648	2026-08-18	U-2594		2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648	2026-08-18	U-3188		2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648	2026-08-18	U-3189		2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648	2026-08-18	U-3190		2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8906851	2026-08-18	U-2593		2015-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8906851	2026-08-18	U-2589		2015-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8906851	2026-08-18	U-2588		2015-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8906851	2026-08-18	U-2590		2015-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8906851	2026-08-18	U-3190		2015-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8906851	2026-08-18	U-3189		2015-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8906851	2026-08-18	U-3188		2015-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092	2026-08-18	U-2593		2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092	2026-08-18	U-2594		2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092	2026-08-18	U-2595		2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092	2026-08-18	U-2596		2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092	2026-08-18	U-2590		2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092	2026-08-18	U-2588		2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092	2026-08-18	U-2589		2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092	2026-08-18	U-3190		2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092	2026-08-18	U-3189		2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092	2026-08-18	U-3188		2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8329648*PED	2027-02-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8906851*PED	2027-02-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	9884092*PED	2027-02-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8501698	2027-06-20	U-2588	Drug product	2017-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8501698*PED	2027-12-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8361972	2028-03-21	U-2588		2017-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-001	8361972*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-002	6515117	2025-10-04	U-2588	Drug substance, Drug product	2017-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-002	6515117*PED	2026-04-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-002	8329648	2026-08-18	U-2596		2014-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022200-002	8329648	2026-08-18	U-2595		2014-03-28	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022200-001	NPP	2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022200-001	PED	2025-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022200-002	NPP	2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022200-002	PED	2025-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022200-001	NPP	2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022200-001	PED	2025-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022200-002	NPP	2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022200-002	PED	2025-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022200-001	NPP	2024-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022200-001	PED	2025-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022200-002	NPP	2024-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022200-002	PED	2025-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022200-001	NPP	2024-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022200-001	PED	2025-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022200-002	NPP	2024-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022200-002	PED	2025-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022200-001	NPP	2024-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022200-001	PED	2025-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022200-002	NPP	2024-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022200-002	PED	2025-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022200-001	NPP	2024-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022200-001	PED	2025-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022200-002	NPP	2024-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022200-002	PED	2025-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022200-001	NPP	2024-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022200-001	PED	2025-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022200-002	NPP	2024-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022200-002	PED	2025-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022200-001	NPP	2024-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022200-001	PED	2025-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022200-002	NPP	2024-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022200-002	PED	2025-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022200-001	NPP	2024-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022200-001	PED	2025-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022200-002	NPP	2024-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022200-002	PED	2025-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022200-001	NPP	2024-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022200-001	PED	2025-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022200-002	NPP	2024-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022200-002	PED	2025-01-22	`79d66fd596c7…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-6530-01	EA - Each	0310-6530	14a3f526-e40a-457a-bcec-965506484bc3	1	2019-04-11
0310-6530-04	EA - Each	0310-6530	ef52efa2-1bc2-4a40-9799-3f3e30e3ce22	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EXENATIDE	ACTIVE INGREDIENT	9P1872D4OL	BYDUREON (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE BYDUREON (EXENATIDE) KIT [ASTRAZENECA PHARMACEUTICALS LP]	11
EXENATIDE	ACTIVE MOIETY	9P1872D4OL	BYDUREON (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE BYDUREON (EXENATIDE) KIT [ASTRAZENECA PHARMACEUTICALS LP]	11
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	BYDUREON (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE BYDUREON (EXENATIDE) KIT [ASTRAZENECA PHARMACEUTICALS LP]	11
POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 63000 MW)	INACTIVE INGREDIENT	QD923V64H3	BYDUREON (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE BYDUREON (EXENATIDE) KIT [ASTRAZENECA PHARMACEUTICALS LP]	11
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	BYDUREON (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE BYDUREON (EXENATIDE) KIT [ASTRAZENECA PHARMACEUTICALS LP]	11
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BYDUREON (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE BYDUREON (EXENATIDE) KIT [ASTRAZENECA PHARMACEUTICALS LP]	11
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INACTIVE INGREDIENT	70WT22SF4B	BYDUREON (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE BYDUREON (EXENATIDE) KIT [ASTRAZENECA PHARMACEUTICALS LP]	11
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	BYDUREON (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE BYDUREON (EXENATIDE) KIT [ASTRAZENECA PHARMACEUTICALS LP]	11
SUCROSE	INACTIVE INGREDIENT	C151H8M554	BYDUREON (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE BYDUREON (EXENATIDE) KIT [ASTRAZENECA PHARMACEUTICALS LP]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	BYDUREON (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE BYDUREON (EXENATIDE) KIT [ASTRAZENECA PHARMACEUTICALS LP]	11

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9P1872D4OL	EXENATIDE	141758-74-9	EXENATIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-6530-01	00310653001	1 CARTRIDGE in 1 TRAY (0310-6530-01) > .65 mL in 1 CARTRIDGE	1 cartridge	2014-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BYDUREON	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2022-12-21	HUMAN PRESCRIPTION DRUG LABEL	32