ARBLI

Product NDC: 83245-053
Requested package NDC: 83245-053-06
11-digit product format: 832450053
Labeler code: 83245
Product ID: 83245-053_0d6183d3-e8e3-416e-a359-9348c61ac736
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: losartan potassium
Dosage form: SUSPENSION
Route: ORAL
Labeler: Scienture LLC
Application: NDA218772
Marketing category: NDA
Marketing start: 2025-03-19
Substance: LOSARTAN POTASSIUM
Active strength: 10 mg/mL
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	83245-053	83245-053-06	I	Inactivated by FDA		excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`

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
N218772-001	ARBLI	LOSARTAN POTASSIUM	10MG/ML	SUSPENSION / ORAL		RLD, RS	2025-03-13

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218772-001	11890273	2041-10-07		Drug product	2025-04-04
N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04
N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04
N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04
N218772-001	12605365	2041-10-07	U-4159	Drug product	2026-05-01
N218772-001	12605365	2041-10-07	U-4160	Drug product	2026-05-01

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218772-001	12605365	2041-10-07	U-4159	Drug product	2026-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218772-001	12605365	2041-10-07	U-4160	Drug product	2026-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218772-001	12605365	2041-10-07	U-4159	Drug product	2026-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218772-001	12605365	2041-10-07	U-4160	Drug product	2026-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	12605365	2041-10-07	U-4159	Drug product	2026-05-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	12605365	2041-10-07	U-4160	Drug product	2026-05-01	`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: ARBLI
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOSARTAN POTASSIUM	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3ST302B24A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2709039	Internal RxNorm lookup
2709046	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
afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0d341e63-aee5-498b-bf9a-b53a43963acf	Product name	1	20260105
de29c5c0-90ba-29da-d7ab-0500274708be	Product name	6	20241009
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-03-20	These highlights do not include all the information needed to use ARBLI safely and effectively. See full prescribing information for ARBLI. ARBLI (losartan potassium) oral suspension, for oral use Initial U.S. Approval: 1995
2025-03-20	These highlights do not include all the information needed to use ARBLI safely and effectively. See full prescribing information for ARBLI. ARBLI (losartan potassium) oral suspension, for oral use Initial U.S. Approval: 1995
2025-01-30	These highlights do not include all the information needed to use ARBLI safely and effectively. See full prescribing information for ARBLI. ARBLI (losartan potassium) oral suspension, for oral use Initial U.S. Approval: 1995
2025-01-30	These highlights do not include all the information needed to use ARBLI safely and effectively. See full prescribing information for ARBLI. ARBLI (losartan potassium) oral suspension, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83245-053-06	ARBLI	1 in 1 CARTON	SUSPENSION	1		19
83245-053-06	ARBLI	165 mL in 1 BOTTLE	SUSPENSION	165		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83245-053-06	ML - Milliliter	83245-053	115c4f96-403c-4a1f-8930-e7331acc55bd	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83245-053	ARBLI (LOSARTAN POTASSIUM) SUSPENSION [SCIENTURE LLC]	18	Current NDC, 2 package rows	20250406_afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARBLI	LOSARTAN POTASSIUM	Scienture LLC	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218772 application number: NDA218772 ndc (package): 83245-053-06 ndc (product): 83245-053 ndc11 (package): 83245005306

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3ST302B24A	LOSARTAN POTASSIUM	124750-99-8	LOSARTAN POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2709046	Arbli 10 MG/mL Oral Suspension	PSN	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	19
2709039	losartan potassium 10 MG/mL Oral Suspension	PSN	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	19
2709046	losartan potassium 10 MG/ML Oral Suspension [Arbli]	SBD	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	19
2709039	losartan potassium 10 MG/ML Oral Suspension	SCD	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	19
2709046	Arbli 10 MG (equivalent to losartan 9.2 MG) per 1 mL Oral Suspension	SY	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	19
2709039	losartan K+ 10 MG/ML Oral Suspension	SY	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	19
2709046	losartan K+ 10 MG/ML Oral Suspension [Arbli]	SY	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	19
2709039	losartan Pot 10 MG/ML Oral Suspension	SY	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	19
2709046	losartan Pot 10 MG/ML Oral Suspension [Arbli]	SY	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	19
2709039	losartan potassium 10 MG (equivalent to losartan 9.2 MG) per 1 mL Oral Suspension	SY	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83245-053-06	83245005306	1 BOTTLE in 1 CARTON (83245-053-06) / 165 mL in 1 BOTTLE	1 bottle	2025-03-19	No	No	Current