FDA.reportPublic FDA data

LIRAGLUTIDE

Product NDC
81607-018
11-digit product format
816070018
Labeler code
81607
Product ID
81607-018_026b3564-4bf1-4f85-b7c7-abd03c8d9c3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIRAGLUTIDE
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Orbicular Pharmaceutical Technologies Private Limited
Application
ANDA217590
Marketing category
ANDA
Marketing start
2026-01-21
Substance
LIRAGLUTIDE
Active strength
6 mg/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217590-001LIRAGLUTIDELIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217590-001AP1

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217590-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217590-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-14011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217590-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217590-001AP11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217590-001AP11011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217590-001AP11a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
LIRAGLUTIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIRAGLUTIDE6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
839I73S42AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
897122Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb66a46c-9019-4a98-8e5d-581109facfbaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d8dac6c8-0045-42cf-b357-c3350b4ada5cProduct name220251021
0dd952e2-ff48-4739-9b8d-72ae0b326834Product name220200323
ce962b7e-f9f8-43e6-8d30-41514e79f3e4Product name120190201
2f360a13-6ea8-4c2b-b2ef-10133c2836d9Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81607-018-01LIRAGLUTIDE3 in 1 CARTONINJECTION, SOLUTION31
81607-018-01LIRAGLUTIDE3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION31
81607-018-02LIRAGLUTIDE2 in 1 CARTONINJECTION, SOLUTION21
81607-018-02LIRAGLUTIDE3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION31

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
LIRAGLUTIDELIRAGLUTIDEOrbicular Pharmaceutical Technologies Private Limitedbb66a46c-9019-4a98-8e5d-581109facfba2026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217590
application number: ANDA217590
ndc (product): 81607-018
LIRAGLUTIDELIRAGLUTIDECipla USA Inc.8fe557ae-4ff0-47a2-8ec3-37bb0fbdcc642026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217590
application number: ANDA217590

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897122liraglutide 6 MG/ML in 3 ML Pen InjectorPSNbb66a46c-9019-4a98-8e5d-581109facfba1
8971223 ML liraglutide 6 MG/ML Pen InjectorSCDbb66a46c-9019-4a98-8e5d-581109facfba1
897122liraglutide 18 MG per 3 ML Pen InjectorSYbb66a46c-9019-4a98-8e5d-581109facfba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81607-018-01816070018013 SYRINGE, PLASTIC in 1 CARTON (81607-018-01) / 3 mL in 1 SYRINGE, PLASTIC2026-01-21NoNoCurrent
81607-018-02816070018022 SYRINGE, PLASTIC in 1 CARTON (81607-018-02) / 3 mL in 1 SYRINGE, PLASTIC2026-01-21NoNoCurrent