liraglutide

Product NDC: 69097-910
11-digit product format: 690970910
Labeler code: 69097
Product ID: 69097-910_d559ce6c-9334-44c2-b780-4ce15f91b6be
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: liraglutide
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Cipla USA Inc.
Application: ANDA217234
Marketing category: ANDA
Marketing start: 2026-02-25
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217234-001	LIRAGLUTIDE	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP2		2026-02-24

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A217234-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP2		2026-02-24	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217234-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP2		2026-02-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217234-001	AP2	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217234-001	AP2	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIRAGLUTIDE	6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
839I73S42A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2735350	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
22c86976-9657-4dd0-8fff-0c3f3f08357c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d8dac6c8-0045-42cf-b357-c3350b4ada5c	Product name	2	20251021
0dd952e2-ff48-4739-9b8d-72ae0b326834	Product name	2	20200323
ce962b7e-f9f8-43e6-8d30-41514e79f3e4	Product name	1	20190201
2f360a13-6ea8-4c2b-b2ef-10133c2836d9	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69097-910-55	liraglutide	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3	3
69097-910-55	liraglutide	5 in 1 CARTON	INJECTION, SOLUTION	5	3
69097-910-68	liraglutide	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3	3
69097-910-68	liraglutide	3 in 1 CARTON	INJECTION, SOLUTION	3	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-910-55	ML - Milliliter	69097-910	4a0573ab-d9d6-4c68-bc06-626c3cfbda7d	1	2026-03-17

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
liraglutide	LIRAGLUTIDE	Cipla USA Inc.	22c86976-9657-4dd0-8fff-0c3f3f08357c	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217234 application number: ANDA217234 ndc (product): 69097-910
liraglutide	LIRAGLUTIDE	Orbicular Pharmaceutical Technologies Private Limited	d2bfc30a-8392-4255-a4d8-fa0b8d1659b2	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217234 application number: ANDA217234

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
839I73S42A	LIRAGLUTIDE	204656-20-2	LIRAGLUTIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2735350	liraglutide 6 MG/ML in 3 mL Weight Management Pen Injector	PSN	22c86976-9657-4dd0-8fff-0c3f3f08357c	3
2735350	Weight Management 3 ML liraglutide 6 MG/ML Pen Injector	SCD	22c86976-9657-4dd0-8fff-0c3f3f08357c	3
2735350	liraglutide 18 MG per 3 ML Weight Management Pen Injector	SY	22c86976-9657-4dd0-8fff-0c3f3f08357c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69097-910-55	69097091055	5 SYRINGE, PLASTIC in 1 CARTON (69097-910-55) / 3 mL in 1 SYRINGE, PLASTIC	2026-02-25	No	No	Current
69097-910-68	69097091068	3 SYRINGE, PLASTIC in 1 CARTON (69097-910-68) / 3 mL in 1 SYRINGE, PLASTIC	2026-02-25	No	No	Current