FDA.reportPublic FDA data

liraglutide

Product NDC
81607-019
11-digit product format
816070019
Labeler code
81607
Product ID
81607-019_d6116799-f4f4-4bf4-a71d-8be7f105d607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
liraglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Orbicular Pharmaceutical Technologies Private Limited
Application
ANDA217234
Marketing category
ANDA
Marketing start
2026-02-26
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
A217234-001LIRAGLUTIDELIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP22026-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217234-001AP2

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 06:07:402026-07A217234-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP22026-02-24caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217234-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP22026-02-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217234-001AP21caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217234-001AP21a50c72e98297…

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
2735350Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2bfc30a-8392-4255-a4d8-fa0b8d1659b2Available 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
81607-019-01liraglutide3 in 1 CARTONINJECTION, SOLUTION32
81607-019-02liraglutide5 in 1 CARTONINJECTION, SOLUTION52
81607-019-03liraglutide3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION32

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
liraglutideLIRAGLUTIDECipla USA Inc.22c86976-9657-4dd0-8fff-0c3f3f08357c2026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217234
application number: ANDA217234
liraglutideLIRAGLUTIDEOrbicular Pharmaceutical Technologies Private Limitedd2bfc30a-8392-4255-a4d8-fa0b8d1659b22026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217234
application number: ANDA217234
ndc (product): 81607-019

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2735350liraglutide 6 MG/ML in 3 mL Weight Management Pen InjectorPSNd2bfc30a-8392-4255-a4d8-fa0b8d1659b22
2735350Weight Management 3 ML liraglutide 6 MG/ML Pen InjectorSCDd2bfc30a-8392-4255-a4d8-fa0b8d1659b22
2735350liraglutide 18 MG per 3 ML Weight Management Pen InjectorSYd2bfc30a-8392-4255-a4d8-fa0b8d1659b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81607-019-01816070019013 SYRINGE, PLASTIC in 1 CARTON (81607-019-01) / 3 mL in 1 SYRINGE, PLASTIC (81607-019-03) 2026-02-26NoNoCurrent
81607-019-02816070019025 SYRINGE, PLASTIC in 1 CARTON (81607-019-02) / 3 mL in 1 SYRINGE, PLASTIC (81607-019-03) 2026-02-26NoNoCurrent
81607-019-03816070019033 mL in 1 SYRINGE, PLASTIC3 mlHistorical