NDC 0310-6540

BYDUREON BCise

Exenatide

BYDUREON BCise is a Subcutaneous Injection, Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Exenatide.

Product ID0310-6540_249a148a-2c5a-4411-843b-f98986d5fea6
NDC0310-6540
Product TypeHuman Prescription Drug
Proprietary NameBYDUREON BCise
Generic NameExenatide
Dosage FormInjection, Suspension, Extended Release
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-12-01
Marketing CategoryNDA / NDA
Application NumberNDA209210
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameEXENATIDE
Active Ingredient Strength2 mg/.85mL
Pharm ClassesGLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0310-6540-04

4 CARTRIDGE in 1 CARTON (0310-6540-04) > .85 mL in 1 CARTRIDGE (0310-6540-01)
Marketing Start Date2017-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-6540-85 [00310654085]

BYDUREON BCise INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA209210
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-01

NDC 0310-6540-01 [00310654001]

BYDUREON BCise INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA209210
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-01

NDC 0310-6540-04 [00310654004]

BYDUREON BCise INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA209210
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-01

Drug Details

Pharmacological Class

  • GLP-1 Receptor Agonist [EPC]
  • Glucagon-Like Peptide 1 [CS]
  • Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]

NDC Crossover Matching brand name "BYDUREON BCise" or generic name "Exenatide"

NDCBrand NameGeneric Name
0310-6540BYDUREON BCiseexenatide
0310-6520BYDUREONexenatide
0310-6530BYDUREONexenatide
0310-6512Byettaexenatide
0310-6524Byettaexenatide

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