Home NDC 0310-6512 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021773-001 BYETTA EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 N021773-002 BYETTA EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28
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 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Byetta Active Ingredients# Ingredient, Strength table Ingredient Strength EXENATIDE 250 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9P1872D4OL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 847910 Internal RxNorm lookup 847913 Internal RxNorm lookup 847915 Internal RxNorm lookup 847917 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0310-6512-01 Byetta 1.2 mL in 1 CARTRIDGE INJECTION 1.2 26 0310-6512-01 Byetta 1 in 1 CARTON INJECTION 1 26 0310-6512-85 Byetta 1 in 1 CARTON INJECTION 1 26 0310-6512-85 Byetta 1.2 mL in 1 CARTRIDGE INJECTION 1.2 26
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-6512 BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP] 24 Current NDC, Legacy NDC, 4 package rows 20241113_53d03c03-ebf7-418d-88a8-533eabd2ee4f.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 847913 Byetta 10 MCG, 250 MCG/ML in 2.4 mL Pen Injector PSN 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847917 Byetta 5 MCG, 250 MCG/ML in 1.2 mL Pen Injector PSN 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847910 exenatide 10 MCG, 250 MCG/ML in 2.4 mL Pen Injector PSN 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847915 exenatide 5 MCG, 250 MCG/ML in 1.2 mL Pen Injector PSN 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847917 60 ACTUAT exenatide 0.005 MG/ACTUAT Pen Injector [Byetta] SBD 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847913 60 ACTUAT exenatide 0.01 MG/ACTUAT Pen Injector [Byetta] SBD 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847915 60 ACTUAT exenatide 0.005 MG/ACTUAT Pen Injector SCD 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847910 60 ACTUAT exenatide 0.01 MG/ACTUAT Pen Injector SCD 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847917 60 ACTUAT Byetta 0.005 MG/ACTUAT Pen Injector SY 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847913 60 ACTUAT Byetta 0.01 MG/ACTUAT Pen Injector SY 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847913 Byetta 10 MCG/ACTUAT Pen Injector, 60 ACTUAT SY 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847917 Byetta 250 MCG/ML Pen Injector, 1.2 ML SY 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847913 Byetta 250 MCG/ML Pen Injector, 2.4 ML SY 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847917 Byetta 5 MCG/ACTUAT Pen Injector, 60 ACTUAT SY 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847910 exenatide 10 MCG/ACTUAT Pen Injector, 60 ACTUAT SY 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847915 exenatide 250 MCG/ML Pen Injector, 1.2 ML SY 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847910 exenatide 250 MCG/ML Pen Injector, 2.4 ML SY 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26 847915 exenatide 5 MCG/ACTUAT Pen Injector, 60 ACTUAT SY 53d03c03-ebf7-418d-88a8-533eabd2ee4f 26
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0310-6512-01 00310651201 1 CARTRIDGE in 1 CARTON (0310-6512-01) / 1.2 mL in 1 CARTRIDGE 1 cartridge 2014-12-10 2026-12-31 No No Current 0310-6512-85 00310651285 1 in 1 CARTON Historical