FDA.reportPublic FDA data

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#

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0310-6540DDiscontinued by firm2026-07-31
excluded packagepackage0310-65400310-6540-04DDiscontinued by firm2026-07-31
excluded packagepackage0310-65400310-6540-85DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209210-001BYDUREON BCISEEXENATIDE SYNTHETIC2MG/0.85ML (2MG/0.85ML)SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUSRLD2017-10-20

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209210-00165151172025-10-04U-2588Drug substance, Drug product2019-08-21
N209210-0016515117*PED2026-04-04Pediatric extension
N209210-00183296482026-08-18U-25882017-11-03
N209210-00183296482026-08-18U-25892017-11-03
N209210-00183296482026-08-18U-25902017-11-03
N209210-00183296482026-08-18U-25932017-11-03
N209210-00183296482026-08-18U-25942017-11-03
N209210-00183296482026-08-18U-25952017-11-03
N209210-00183296482026-08-18U-25962017-11-03
N209210-00183296482026-08-18U-31882017-11-03
N209210-00183296482026-08-18U-31892017-11-03
N209210-00183296482026-08-18U-31902017-11-03
N209210-00189068512026-08-18U-25882017-11-03
N209210-00189068512026-08-18U-25892017-11-03
N209210-00189068512026-08-18U-25902017-11-03
N209210-00189068512026-08-18U-25932017-11-03
N209210-00189068512026-08-18U-25972017-11-03
N209210-00189068512026-08-18U-31882017-11-03
N209210-00189068512026-08-18U-31892017-11-03
N209210-00189068512026-08-18U-31902017-11-03
N209210-00198840922026-08-18U-25882018-03-06
N209210-00198840922026-08-18U-25892018-03-06
N209210-00198840922026-08-18U-25902018-03-06
N209210-00198840922026-08-18U-25932018-03-06
N209210-00198840922026-08-18U-25942018-03-06
N209210-00198840922026-08-18U-25952018-03-06
N209210-00198840922026-08-18U-25962018-03-06
N209210-00198840922026-08-18U-25972018-03-06
N209210-00198840922026-08-18U-31882018-03-06
N209210-00198840922026-08-18U-31892018-03-06
N209210-00198840922026-08-18U-31902018-03-06
N209210-0018329648*PED2027-02-18Pediatric extension
N209210-0018906851*PED2027-02-18Pediatric extension
N209210-0019884092*PED2027-02-18Pediatric extension
N209210-00185016982027-06-20U-25882019-08-21
N209210-0018501698*PED2027-12-20Pediatric extension
N209210-00183619722028-03-21U-25882019-08-21
N209210-0018361972*PED2028-09-21Pediatric extension
N209210-00188950332030-10-04U-2589Drug product2017-11-03
N209210-00188950332030-10-04U-2590Drug product2017-11-03
N209210-00188950332030-10-04U-2597Drug product2017-11-03
N209210-00188950332030-10-04U-2601Drug product2017-11-03
N209210-00188950332030-10-04U-2602Drug product2017-11-03
N209210-00188950332030-10-04U-3188Drug product2017-11-03
N209210-00188950332030-10-04U-3189Drug product2017-11-03
N209210-00188950332030-10-04U-3190Drug product2017-11-03
N209210-0018895033*PED2031-04-04Pediatric 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N209210-001BYDUREON BCISE2MG/0.85ML (2MG/0.85ML)SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUSRLD2017-10-20a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N209210-00165151172025-10-04U-2588Drug substance, Drug product2019-08-21a50c72e98297…
2026-08-01 22:54:322026-06N209210-0016515117*PED2026-04-04Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N209210-00183296482026-08-18U-25902017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00183296482026-08-18U-25932017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00183296482026-08-18U-25942017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00183296482026-08-18U-25962017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00183296482026-08-18U-25952017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00183296482026-08-18U-25882017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00183296482026-08-18U-25892017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00183296482026-08-18U-31892017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00183296482026-08-18U-31882017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00183296482026-08-18U-31902017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00189068512026-08-18U-25902017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00189068512026-08-18U-25932017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00189068512026-08-18U-25972017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00189068512026-08-18U-25892017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00189068512026-08-18U-31882017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00189068512026-08-18U-31892017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00189068512026-08-18U-25882017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00189068512026-08-18U-31902017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-25932018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-25892018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-25942018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-25962018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-25972018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-25952018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-25902018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-25882018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-31882018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-31902018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-00198840922026-08-18U-31892018-03-06a50c72e98297…
2026-08-01 22:54:322026-06N209210-0018329648*PED2027-02-18Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N209210-0018906851*PED2027-02-18Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N209210-0019884092*PED2027-02-18Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N209210-00185016982027-06-20U-25882019-08-21a50c72e98297…
2026-08-01 22:54:322026-06N209210-0018501698*PED2027-12-20Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N209210-00183619722028-03-21U-25882019-08-21a50c72e98297…
2026-08-01 22:54:322026-06N209210-0018361972*PED2028-09-21Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N209210-00188950332030-10-04U-2597Drug product2017-11-03a50c72e98297…
2026-08-01 22:54:322026-06N209210-00188950332030-10-04U-2590Drug product2017-11-03a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910a43af-bf3b-4a75-af76-a237c61fbc82Product name120250717
8f64a1da-980a-4c97-8c3f-c572643b48f9Product name120171212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-6540-01ML - Milliliter0310-65403844da3e-9c51-4bfd-9f48-3281e2253cce12017-12-14
0310-6540-04ML - Milliliter0310-6540cde5b8f4-7ea4-4bd3-a394-e409c883f4e912017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-6540BYDUREON BCISE (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]38Legacy NDC20241109_2d18cfc4-e0de-4814-a712-c1b7c504bff5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-6540-04003106540044 CARTRIDGE in 1 CARTON (0310-6540-04) > .85 mL in 1 CARTRIDGE (0310-6540-01) 4 cartridge2017-12-010000-00-00NoNoCurrent
0310-6540-85003106540851 CARTRIDGE in 1 CARTON (0310-6540-85) > .85 mL in 1 CARTRIDGE1 cartridge2017-12-010000-00-00YesNoCurrent