Home NDC 70121-1685 Exenatide
Product NDC 70121-1685
11-digit product format 701211685
Labeler code 70121
Product ID 70121-1685_b5cc060b-1669-4bee-b0f7-911b5d188547
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Exenatide
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA206697
Marketing category ANDA
Marketing start 2024-11-22
Marketing end 2027-06-30
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
Listing certified through 2027-12-31
Current FDA listing Yes 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 A206697-001 EXENATIDE SYNTHETIC EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 A206697-002 EXENATIDE SYNTHETIC EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19
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 2026-08-18 06:07:40 2026-07 A206697-001 EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206697-002 EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206697-001 EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206697-002 EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206697-001 EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206697-002 EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206697-001 EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206697-002 EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206697-001 EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP 2024-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206697-002 EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP 2024-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206697-001 EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP 2024-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206697-002 EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP 2024-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206697-001 EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP 2024-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206697-002 EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP 2024-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206697-001 EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP 2024-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206697-002 EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS AP 2024-11-19 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206697-001 EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206697-002 EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 a50c72e98297…
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 A206697-001 AP 1 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206697-002 AP 1 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206697-001 AP 1 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206697-002 AP 1 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206697-001 AP 1 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206697-002 AP 1 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206697-001 AP 1 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206697-002 AP 1 2680178bc6a6…
Additional Listing Data#
Finished product Yes
Brand name base Exenatide 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 847910 Internal RxNorm lookup 847915 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 70121-1685-1 Exenatide 1 in 1 CARTON INJECTION 1 16 70121-1685-1 Exenatide 1.2 mL in 1 CARTRIDGE INJECTION 1.2 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-1685 EXENATIDE INJECTION [AMNEAL PHARMACEUTICALS LLC] 11 Current NDC, 2 package rows 20241123_e6cb5c8f-e97f-4a6a-95a4-939fd2393949.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70121-1685-1 70121168501 1 CARTRIDGE in 1 CARTON (70121-1685-1) / 1.2 mL in 1 CARTRIDGE 1 cartridge 2024-11-22 2027-06-30 No No Historical