Home NDC 76282-720 LANREOTIDE ACETATE
Product NDC 76282-720
11-digit product format 762820720
Labeler code 76282
Product ID 76282-720_054af266-c850-45c8-b027-d810d7d5f0ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LANREOTIDE ACETATE
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler EXELAN PHARMACEUTICALS, INC.
Application ANDA217193
Marketing category ANDA
Marketing start 2025-05-30
Substance LANREOTIDE ACETATE
Active strength 120 mg/.5mL
Pharmacologic classes Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217193-001 LANREOTIDE ACETATE LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 A217193-002 LANREOTIDE ACETATE LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 A217193-003 LANREOTIDE ACETATE LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 · 48 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 2026-09-14 22:38:34 2026-08 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217193-002 LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217193-003 LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217193-001 LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS AB 2024-05-21 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 48 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217193-002 AB 1 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217193-003 AB 1 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217193-001 AB 1 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217193-002 AB 1 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217193-003 AB 1 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217193-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217193-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217193-003 AB 1 a50c72e98297…
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LANREOTIDE ACETATE 120 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IEU56G3J9C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 749811 Internal RxNorm lookup 749814 Internal RxNorm lookup 749817 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 76282-720-67 LANREOTIDE ACETATE 1 in 1 POUCH INJECTION 1 2 76282-720-67 LANREOTIDE ACETATE 1 in 1 CARTON INJECTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76282-720 LANREOTIDE ACETATE INJECTION [EXELAN PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20240601_eec3c37e-83a7-4195-bccf-cd5973459eef.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76282-720-67 76282072067 1 POUCH in 1 CARTON (76282-720-67) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE 1 pouch 2025-05-30 No No Current