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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2005-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2005-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2005-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2005-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2005-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2005-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2005-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2005-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021773-001 AP 1 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021773-002 AP 1 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021773-001 AP 1 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021773-002 AP 1 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021773-001 AP 1 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021773-002 AP 1 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021773-001 AP 1 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021773-002 AP 1 2680178bc6a6…
Observed Orange Book patent history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 observed states.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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