BYDUREON

Product NDC: 0310-6520
11-digit product format: 003106520
Labeler code: 0310
Product ID: 0310-6520_32b6aa46-4943-4bd2-b25f-34b2acbe0ba6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: exenatide
Dosage form: KIT
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA022200
Marketing category: NDA
Marketing start: 2015-02-01
Marketing end: 2020-11-30
Active strength: 0
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0310-6520		D	Discontinued by firm		2026-07-31
excluded package	package	0310-6520	0310-6520-04	D	Discontinued by firm		2026-07-31

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2012-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2014-02-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022200-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2017-11-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2590		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2589		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2595		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2593		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2596		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2588		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2594		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-3188		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-3189		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-3190		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-2593		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-2589		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-2588		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-2590		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-3190		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-3189		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-3188		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2593		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2594		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2595		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2596		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2590		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2588		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2589		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-3190		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-3189		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-3188		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8501698	2027-06-20	U-2588	Drug product	2017-11-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8361972	2028-03-21	U-2588		2017-11-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8361972*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-002	6515117	2025-10-04	U-2588	Drug substance, Drug product	2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-002	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-002	8329648	2026-08-18	U-2596		2014-03-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-002	8329648	2026-08-18	U-2595		2014-03-28	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-6520-04	EA - Each	0310-6520	2ced115f-ec1e-4ac8-9c11-7a0fb5b020c8	1	2015-03-03

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

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