FDA.reportPublic FDA data

Byetta

Product NDC
0310-6512
11-digit product format
003106512
Labeler code
0310
Product ID
0310-6512_7333a7dd-9449-4c61-b36d-c5d8d7cc239b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
exenatide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA021773
Marketing category
NDA
Marketing start
2014-12-10
Marketing end
2026-12-31
Substance
EXENATIDE
Active strength
250 ug/mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Byetta

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EXENATIDE250 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9P1872D4OL
Rxcui847910, 847913, 847915, 847917

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910a43af-bf3b-4a75-af76-a237c61fbc82Product name120250717
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
8f64a1da-980a-4c97-8c3f-c572643b48f9Product name120171212
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-6512-01Byetta1.2 mL in 1 CARTRIDGEINJECTION1.226
0310-6512-01Byetta1 in 1 CARTONINJECTION126
0310-6512-85Byetta1 in 1 CARTONINJECTION126
0310-6512-85Byetta1.2 mL in 1 CARTRIDGEINJECTION1.226

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-6512-01ML - Milliliter0310-65125003b18e-021b-4e88-8887-0a25cd933a2912015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
exenatideACTIVE INGREDIENT9P1872D4OLBYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]2
exenatideACTIVE MOIETY9P1872D4OLBYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]2
acetic acidINACTIVE INGREDIENTQ40Q9N063PBYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]2
mannitolINACTIVE INGREDIENT3OWL53L36ABYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]2
metacresolINACTIVE INGREDIENTGGO4Y809LOBYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]2
sodium acetateINACTIVE INGREDIENT4550K0SC9BBYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]2
waterINACTIVE INGREDIENT059QF0KO0RBYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-6512BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]24Current NDC, Legacy NDC, 4 package rows20241113_53d03c03-ebf7-418d-88a8-533eabd2ee4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847913Byetta 10 MCG, 250 MCG/ML in 2.4 mL Pen InjectorPSN53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847917Byetta 5 MCG, 250 MCG/ML in 1.2 mL Pen InjectorPSN53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847910exenatide 10 MCG, 250 MCG/ML in 2.4 mL Pen InjectorPSN53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847915exenatide 5 MCG, 250 MCG/ML in 1.2 mL Pen InjectorPSN53d03c03-ebf7-418d-88a8-533eabd2ee4f26
84791760 ACTUAT exenatide 0.005 MG/ACTUAT Pen Injector [Byetta]SBD53d03c03-ebf7-418d-88a8-533eabd2ee4f26
84791360 ACTUAT exenatide 0.01 MG/ACTUAT Pen Injector [Byetta]SBD53d03c03-ebf7-418d-88a8-533eabd2ee4f26
84791560 ACTUAT exenatide 0.005 MG/ACTUAT Pen InjectorSCD53d03c03-ebf7-418d-88a8-533eabd2ee4f26
84791060 ACTUAT exenatide 0.01 MG/ACTUAT Pen InjectorSCD53d03c03-ebf7-418d-88a8-533eabd2ee4f26
84791760 ACTUAT Byetta 0.005 MG/ACTUAT Pen InjectorSY53d03c03-ebf7-418d-88a8-533eabd2ee4f26
84791360 ACTUAT Byetta 0.01 MG/ACTUAT Pen InjectorSY53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847913Byetta 10 MCG/ACTUAT Pen Injector, 60 ACTUATSY53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847917Byetta 250 MCG/ML Pen Injector, 1.2 MLSY53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847913Byetta 250 MCG/ML Pen Injector, 2.4 MLSY53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847917Byetta 5 MCG/ACTUAT Pen Injector, 60 ACTUATSY53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847910exenatide 10 MCG/ACTUAT Pen Injector, 60 ACTUATSY53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847915exenatide 250 MCG/ML Pen Injector, 1.2 MLSY53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847910exenatide 250 MCG/ML Pen Injector, 2.4 MLSY53d03c03-ebf7-418d-88a8-533eabd2ee4f26
847915exenatide 5 MCG/ACTUAT Pen Injector, 60 ACTUATSY53d03c03-ebf7-418d-88a8-533eabd2ee4f26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-6512-01003106512011 CARTRIDGE in 1 CARTON (0310-6512-01) / 1.2 mL in 1 CARTRIDGE1 cartridge2014-12-102026-12-31NoNoCurrent
0310-6512-85003106512851 in 1 CARTONHistorical