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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217193-001LANREOTIDE ACETATELANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-21
A217193-002LANREOTIDE ACETATELANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-21
A217193-003LANREOTIDE ACETATELANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A217193-001AB
A217193-002AB
A217193-003AB

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 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217193-002LANREOTIDE ACETATEEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTION / SUBCUTANEOUSAB2024-05-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217193-003LANREOTIDE ACETATEEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTION / SUBCUTANEOUSAB2024-05-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217193-001LANREOTIDE ACETATEEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTION / SUBCUTANEOUSAB2024-05-211e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217193-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217193-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217193-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217193-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217193-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217193-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217193-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217193-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217193-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217193-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217193-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217193-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217193-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217193-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217193-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217193-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217193-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217193-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217193-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217193-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217193-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217193-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217193-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217193-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217193-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217193-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217193-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217193-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217193-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217193-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217193-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217193-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217193-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217193-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217193-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217193-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217193-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217193-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217193-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217193-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
LANREOTIDE ACETATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANREOTIDE ACETATE120 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IEU56G3J9CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
749811Internal RxNorm lookup
749814Internal RxNorm lookup
749817Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eec3c37e-83a7-4195-bccf-cd5973459eefAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3340e9ad-5e0e-4ddc-aa91-4357df39a30fProduct name220250221
e9869da2-9f36-4263-93de-4156429775d7Product name120220720
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-720-67LANREOTIDE ACETATE1 in 1 POUCHINJECTION12
76282-720-67LANREOTIDE ACETATE1 in 1 CARTONINJECTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-720-67ML - Milliliter76282-720f61aff25-f88f-4593-ac8a-5d5265e8bd9912024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-720LANREOTIDE ACETATE INJECTION [EXELAN PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240601_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LANREOTIDE ACETATELANREOTIDE ACETATEEXELAN PHARMACEUTICALS, INC.eec3c37e-83a7-4195-bccf-cd5973459eef2025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217193
application number: ANDA217193
ndc (product): 76282-720
LANREOTIDE ACETATELANREOTIDE ACETATECipla USA Inc.2892b4c3-0329-4d29-97ff-3b45283bbab12025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217193
application number: ANDA217193

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749814lanreotide 120 MG in 0.5 ML Prefilled SyringePSNeec3c37e-83a7-4195-bccf-cd5973459eef2
749811lanreotide 60 MG in 0.2 ML Prefilled SyringePSNeec3c37e-83a7-4195-bccf-cd5973459eef2
749817lanreotide 90 MG in 0.3 ML Prefilled SyringePSNeec3c37e-83a7-4195-bccf-cd5973459eef2
7498110.2 ML lanreotide 300 MG/ML Prefilled SyringeSCDeec3c37e-83a7-4195-bccf-cd5973459eef2
7498170.3 ML lanreotide 300 MG/ML Prefilled SyringeSCDeec3c37e-83a7-4195-bccf-cd5973459eef2
7498140.5 ML lanreotide 240 MG/ML Prefilled SyringeSCDeec3c37e-83a7-4195-bccf-cd5973459eef2
7498140.5 ML lanreotide 240 MG/ML (as lanreotide acetate) Prefilled SyringeSYeec3c37e-83a7-4195-bccf-cd5973459eef2
749814lanreotide 120 MG per 0.5 ML Prefilled SyringeSYeec3c37e-83a7-4195-bccf-cd5973459eef2
749811lanreotide 60 MG per 0.2 ML (as lanreotide acetate) Prefilled SyringeSYeec3c37e-83a7-4195-bccf-cd5973459eef2
749817lanreotide 90 MG per 0.3 ML (as lanreotide acetate) Prefilled SyringeSYeec3c37e-83a7-4195-bccf-cd5973459eef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-720-67762820720671 POUCH in 1 CARTON (76282-720-67) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE1 pouch2025-05-30NoNoCurrent