FDA.reportPublic FDA data

Liraglutide

Product NDC
0480-7250
11-digit product format
004807250
Labeler code
0480
Product ID
0480-7250_4df44cd9-cb11-46b6-ba6c-88ff963ec414
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Liraglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA214568
Marketing category
ANDA
Marketing start
2025-08-28
Marketing end
2027-09-30
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
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
A214568-001LIRAGLUTIDELIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP22025-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214568-001AP2

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A214568-001PC2026-02-24

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 06:07:402026-07A214568-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP22025-08-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214568-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP22025-08-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214568-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP22025-08-2731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214568-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP22025-08-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214568-001AP21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214568-001AP21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214568-001AP2131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214568-001AP21a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07A214568-001PC2026-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214568-001PC2026-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214568-001PC2026-02-2431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214568-001PC2026-02-24a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Liraglutide

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
625ac780-70a9-41e4-a892-bcba0f803f1cAvailable 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
0480-7250-46Liraglutide3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION34
0480-7250-46Liraglutide5 in 1 CARTONINJECTION, SOLUTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-7250-46ML - Milliliter0480-7250829eed5c-805b-4193-93af-718cb4ae689b12025-09-12

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LiraglutideLIRAGLUTIDETeva Pharmaceuticals, Inc.625ac780-70a9-41e4-a892-bcba0f803f1c2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214568
application number: ANDA214568
ndc (product): 0480-7250

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2735350liraglutide 6 MG/ML in 3 mL Weight Management Pen InjectorPSN625ac780-70a9-41e4-a892-bcba0f803f1c4
2735350Weight Management 3 ML liraglutide 6 MG/ML Pen InjectorSCD625ac780-70a9-41e4-a892-bcba0f803f1c4
2735350liraglutide 18 MG per 3 ML Weight Management Pen InjectorSY625ac780-70a9-41e4-a892-bcba0f803f1c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0480-7250-46004807250465 SYRINGE, PLASTIC in 1 CARTON (0480-7250-46) / 3 mL in 1 SYRINGE, PLASTIC2025-08-282027-09-30NoNoHistorical