BYDUREON BCise

Product NDC: 0310-6540
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#

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0310-6540		D	Discontinued by firm	2026-08-17
excluded package	package	0310-6540	0310-6540-04	D	Discontinued by firm	2026-08-17
excluded package	package	0310-6540	0310-6540-85	D	Discontinued by firm	2026-08-17

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-6540-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-6540-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0310-6540-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0310-6540-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0310-6540-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-6540-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-6540-85	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-6540-85	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-6540-85	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-6540-85	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-6540-85	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-6540-85	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-6540-85	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 82 · 3,255 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209210-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2019-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2590		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2593		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2594		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2596		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2595		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2588		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2589		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-3189		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-3188		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-3190		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-2590		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-2593		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-2597		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-2589		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-3188		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-3189		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-2588		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-3190		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2593		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2589		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2594		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2596		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2597		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2595		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2590		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2588		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-3188		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-3190		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-3189		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8501698	2027-06-20	U-2588		2019-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8361972	2028-03-21	U-2588		2019-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8361972*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8895033	2030-10-04	U-2597	Drug product	2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8895033	2030-10-04	U-2590	Drug product	2017-11-03	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 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	N209210-001	NPP	2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209210-001	PED	2025-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209210-001	NPP	2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209210-001	PED	2025-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209210-001	NPP	2024-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209210-001	PED	2025-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209210-001	NPP	2024-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209210-001	PED	2025-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209210-001	NPP	2024-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209210-001	PED	2025-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209210-001	NPP	2024-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209210-001	PED	2025-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209210-001	NPP	2024-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209210-001	PED	2025-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209210-001	NPP	2024-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209210-001	PED	2025-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209210-001	NPP	2024-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209210-001	PED	2025-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209210-001	NPP	2024-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209210-001	PED	2025-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209210-001	NPP	2024-07-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209210-001	PED	2025-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209210-001	NPP	2024-07-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209210-001	PED	2025-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209210-001	NPP	2024-07-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209210-001	PED	2025-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209210-001	M-240	2022-02-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209210-001	PED	2023-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209210-001	NPP	2024-07-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209210-001	PED	2025-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209210-001	M-240	2022-02-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209210-001	PED	2023-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209210-001	NPP	2024-07-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209210-001	PED	2025-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209210-001	M-240	2022-02-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209210-001	PED	2023-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209210-001	NPP	2024-07-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209210-001	PED	2025-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209210-001	NP	2020-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209210-001	M-240	2022-02-15	`bb7c543d1eb4…`

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
0310-6540-85	00310654085	1 CARTRIDGE in 1 CARTON (0310-6540-85) > .85 mL in 1 CARTRIDGE	1 cartridge	2017-12-01	0000-00-00	Yes	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