FDA.reportPublic FDA data

LIRAGLUTIDE

Product NDC
50090-8145
11-digit product format
500908145
Labeler code
50090
Product ID
50090-8145_ffb11702-acf9-42df-be99-144596559095
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIRAGLUTIDE
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
ANDA217590
Marketing category
ANDA
Marketing start
2026-01-22
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 43.

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
2026-09-14 22:38:342026-08A217590-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-1484e616aacf4f…
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
2026-09-14 22:38:342026-08A217590-001AP1184e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
LIRAGLUTIDELIRAGLUTIDECipla USA Inc.8fe557ae-4ff0-47a2-8ec3-37bb0fbdcc642026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217590
application number: ANDA217590

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-8145-0500908145003 SYRINGE, PLASTIC in 1 CARTON (50090-8145-0) / 3 mL in 1 SYRINGE, PLASTIC2026-10-08NoNoHistorical