Liraglutide

Product NDC: 14403-3400
11-digit product format: 144033400
Labeler code: 14403
Product ID: 14403-3400_1a36a385-111a-f5a9-e063-6294a90a29a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Liraglutide
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)
Application: ANDA215503
Marketing category: ANDA
Marketing start: 2024-06-21
Substance: LIRAGLUTIDE
Active strength: 18 mg/3mL
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: 2026-12-31
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215503-001	LIRAGLUTIDE	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP1		2024-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215503-001	AP1

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215503-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP1	2024-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215503-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP1	2024-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215503-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP1	2024-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215503-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP1	2024-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215503-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP	2024-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215503-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP	2024-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215503-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP	2024-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215503-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP	2024-12-23	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215503-001	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP1	2024-12-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215503-001	AP1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215503-001	AP1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215503-001	AP1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215503-001	AP1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215503-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215503-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215503-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215503-001	AP	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215503-001	AP1	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Liraglutide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIRAGLUTIDE	18 mg/3mL

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
897122	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
1a36b801-41e2-2eed-e063-6294a90a6f27	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
14403-3400-1	Liraglutide	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3	4
14403-3400-2	Liraglutide	2 in 1 CARTON	INJECTION, SOLUTION	2	4
14403-3400-1	Liraglutide	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3	3
14403-3400-3	Liraglutide	3 in 1 CARTON	INJECTION, SOLUTION	3	3
14403-3400-1	Liraglutide	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14403-3400	LIRAGLUTIDE INJECTION, SOLUTION [HYBIO PHARMACEUTICAL CO., LTD. (PINGSHAN FACTORY)]	4	Current NDC, 2 package rows	20241225_1a372465-d56b-2b80-e063-6394a90a3304.zip
14403-3400	LIRAGLUTIDE INJECTION, SOLUTION [HYBIO PHARMACEUTICAL CO., LTD. (PINGSHAN FACTORY)]	3	Current NDC, 2 package rows	20241225_1a36f43f-d734-97cc-e063-6294a90ae0da.zip
14403-3400	LIRAGLUTIDE INJECTION, SOLUTION [HYBIO PHARMACEUTICAL CO., LTD. (PINGSHAN FACTORY)]	1	Current NDC, 1 package rows	20241224_1a36b801-41e2-2eed-e063-6294a90a6f27.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Liraglutide	LIRAGLUTIDE	Hikma Pharmaceuticals USA Inc.	2100ec49-57b2-4330-ab5f-057ce9b7e4d0	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215503 application number: ANDA215503
Liraglutide	LIRAGLUTIDE	Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)	1a372465-d56b-2b80-e063-6394a90a3304	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215503 application number: ANDA215503 ndc (product): 14403-3400
Liraglutide	LIRAGLUTIDE	Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)	1a36f43f-d734-97cc-e063-6294a90ae0da	2024-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215503 application number: ANDA215503 ndc (product): 14403-3400
Liraglutide	LIRAGLUTIDE	Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)	1a36b801-41e2-2eed-e063-6294a90a6f27	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215503 application number: ANDA215503 ndc (product): 14403-3400

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
897122	liraglutide 6 MG/ML in 3 ML Pen Injector	PSN	1a372465-d56b-2b80-e063-6394a90a3304	4
897122	3 ML liraglutide 6 MG/ML Pen Injector	SCD	1a372465-d56b-2b80-e063-6394a90a3304	4
897122	liraglutide 18 MG per 3 ML Pen Injector	SY	1a372465-d56b-2b80-e063-6394a90a3304	4
897122	liraglutide 6 MG/ML in 3 ML Pen Injector	PSN	1a36f43f-d734-97cc-e063-6294a90ae0da	3
897122	3 ML liraglutide 6 MG/ML Pen Injector	SCD	1a36f43f-d734-97cc-e063-6294a90ae0da	3
897122	liraglutide 18 MG per 3 ML Pen Injector	SY	1a36f43f-d734-97cc-e063-6294a90ae0da	3
897122	liraglutide 6 MG/ML in 3 ML Pen Injector	PSN	1a36b801-41e2-2eed-e063-6294a90a6f27	1
897122	3 ML liraglutide 6 MG/ML Pen Injector	SCD	1a36b801-41e2-2eed-e063-6294a90a6f27	1
897122	liraglutide 18 MG per 3 ML Pen Injector	SY	1a36b801-41e2-2eed-e063-6294a90a6f27	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
14403-3400-1	14403340001	3 mL in 1 SYRINGE, PLASTIC (14403-3400-1)	3 ml	2024-06-21	No	No	Current
14403-3400-2	14403340002	2 SYRINGE, PLASTIC in 1 CARTON (14403-3400-2) / 3 mL in 1 SYRINGE, PLASTIC (14403-3400-1)		2024-12-24	No	No	Current
14403-3400-3	14403340003	3 SYRINGE, PLASTIC in 1 CARTON (14403-3400-3) / 3 mL in 1 SYRINGE, PLASTIC (14403-3400-1)		2024-12-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Liraglutide - Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)	Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)	2024-12-03	HUMAN PRESCRIPTION DRUG LABEL	4
Liraglutide - Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)	Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)	2024-12-02	HUMAN PRESCRIPTION DRUG LABEL	3
Liraglutide - Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)	Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)	2024-06-05	HUMAN PRESCRIPTION DRUG LABEL	1