BYDUREON BCise

Product NDC: 0310-6540
Requested package NDC: 0310-6540-04
11-digit product format: 003106540
Labeler code: 0310
Product ID: 0310-6540_5952c33f-0f0c-448e-bc90-98be65f123ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: exenatide
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: SUBCUTANEOUS
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA209210
Marketing category: NDA
Marketing start: 2017-12-01
Marketing end: 0000-00-00
Substance: EXENATIDE
Active strength: 2 mg/.85mL
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: 2024-12-31
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	0310-6540	0310-6540-04	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209210-001	BYDUREON BCISE	EXENATIDE SYNTHETIC	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2017-10-20

Orange Book patents#

Current patent rows page 1 of 1 · 47 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209210-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2019-08-21
N209210-001	6515117*PED	2026-04-04		Pediatric extension
N209210-001	8329648	2026-08-18	U-2588		2017-11-03
N209210-001	8329648	2026-08-18	U-2589		2017-11-03
N209210-001	8329648	2026-08-18	U-2590		2017-11-03
N209210-001	8329648	2026-08-18	U-2593		2017-11-03
N209210-001	8329648	2026-08-18	U-2594		2017-11-03
N209210-001	8329648	2026-08-18	U-2595		2017-11-03
N209210-001	8329648	2026-08-18	U-2596		2017-11-03
N209210-001	8329648	2026-08-18	U-3188		2017-11-03
N209210-001	8329648	2026-08-18	U-3189		2017-11-03
N209210-001	8329648	2026-08-18	U-3190		2017-11-03
N209210-001	8906851	2026-08-18	U-2588		2017-11-03
N209210-001	8906851	2026-08-18	U-2589		2017-11-03
N209210-001	8906851	2026-08-18	U-2590		2017-11-03
N209210-001	8906851	2026-08-18	U-2593		2017-11-03
N209210-001	8906851	2026-08-18	U-2597		2017-11-03
N209210-001	8906851	2026-08-18	U-3188		2017-11-03
N209210-001	8906851	2026-08-18	U-3189		2017-11-03
N209210-001	8906851	2026-08-18	U-3190		2017-11-03
N209210-001	9884092	2026-08-18	U-2588		2018-03-06
N209210-001	9884092	2026-08-18	U-2589		2018-03-06
N209210-001	9884092	2026-08-18	U-2590		2018-03-06
N209210-001	9884092	2026-08-18	U-2593		2018-03-06
N209210-001	9884092	2026-08-18	U-2594		2018-03-06
N209210-001	9884092	2026-08-18	U-2595		2018-03-06
N209210-001	9884092	2026-08-18	U-2596		2018-03-06
N209210-001	9884092	2026-08-18	U-2597		2018-03-06
N209210-001	9884092	2026-08-18	U-3188		2018-03-06
N209210-001	9884092	2026-08-18	U-3189		2018-03-06
N209210-001	9884092	2026-08-18	U-3190		2018-03-06
N209210-001	8329648*PED	2027-02-18		Pediatric extension
N209210-001	8906851*PED	2027-02-18		Pediatric extension
N209210-001	9884092*PED	2027-02-18		Pediatric extension
N209210-001	8501698	2027-06-20	U-2588		2019-08-21
N209210-001	8501698*PED	2027-12-20		Pediatric extension
N209210-001	8361972	2028-03-21	U-2588		2019-08-21
N209210-001	8361972*PED	2028-09-21		Pediatric extension
N209210-001	8895033	2030-10-04	U-2589	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-2590	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-2597	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-2601	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-2602	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-3188	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-3189	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-3190	Drug product	2017-11-03
N209210-001	8895033*PED	2031-04-04		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	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2017-10-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 47 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	N209210-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2019-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2590		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2593		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2594		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2596		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2595		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2588		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2589		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-3189		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-3188		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-3190		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-2590		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-2593		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-2597		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-2589		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-3188		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-3189		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-2588		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-3190		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2593		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2589		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2594		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2596		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2597		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2595		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2590		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2588		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-3188		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-3190		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-3189		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8501698	2027-06-20	U-2588		2019-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8361972	2028-03-21	U-2588		2019-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8361972*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8895033	2030-10-04	U-2597	Drug product	2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8895033	2030-10-04	U-2590	Drug product	2017-11-03	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
910a43af-bf3b-4a75-af76-a237c61fbc82	Product name	1	20250717
8f64a1da-980a-4c97-8c3f-c572643b48f9	Product name	1	20171212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-6540-01	ML - Milliliter	0310-6540	3844da3e-9c51-4bfd-9f48-3281e2253cce	1	2017-12-14
0310-6540-04	ML - Milliliter	0310-6540	cde5b8f4-7ea4-4bd3-a394-e409c883f4e9	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-6540	BYDUREON BCISE (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	38	Legacy NDC	20241109_2d18cfc4-e0de-4814-a712-c1b7c504bff5.zip

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
0310-6540-04	00310654004	4 CARTRIDGE in 1 CARTON (0310-6540-04) > .85 mL in 1 CARTRIDGE (0310-6540-01)	4 cartridge	2017-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BYDUREON BCise	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	39