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 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 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 2026-08-01 22:54:32 2026-06 A206697-001 EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 a50c72e98297…2026-08-01 22:54:32 2026-06 A206697-002 EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RS 2024-11-19 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 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
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