Home NDC 70121-2517-5 LANREOTIDE ACETATE
Product NDC 70121-2517
Requested package NDC 70121-2517-5
11-digit product format 701212517
Labeler code 70121
Product ID 70121-2517_43b3c820-dda0-4514-92cd-3ad85019d105
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LANREOTIDE ACETATE
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA218217
Marketing category ANDA
Marketing start 2026-09-23
Substance LANREOTIDE ACETATE
Active strength 120 mg/.5mL
Pharmacologic classes Somatostatin Analog [EPC], Somatostatin Receptor 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 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218217-001 LANREOTIDE ACETATE LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2026-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218217-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A218217-001 CGT 2027-03-20
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 2026-10-15 13:18:30 2026-09 A218217-001 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2026-09-18 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A218217-001 AB 1 c2088c7a36db…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-10-15 13:18:30 2026-09 A218217-001 CGT 2027-03-20 c2088c7a36db…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LANREOTIDE ACETATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LANREOTIDE ACETATE 120 mg/.5mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70121-2517-5 70121251705 1 POUCH in 1 CARTON (70121-2517-5) / 1 SYRINGE, PLASTIC in 1 POUCH / .5 mL in 1 SYRINGE, PLASTIC 1 pouch 2026-09-23 No No Current