PREXXARTAN

Product NDC: 76281-155
11-digit product format: 762810155
Labeler code: 76281
Product ID: 76281-155_5c3cc632-c2ca-5d75-e063-6394a90a6c0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREXXARTAN
Dosage form: SOLUTION
Route: ORAL
Labeler: AptaPharma Inc.
Application: NDA209139
Marketing category: NDA
Marketing start: 2026-05-05
Substance: VALSARTAN
Active strength: 4 mg/mL
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209139-001	PREXXARTAN	VALSARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209139-001	AB

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.

Product history page 1 of 2 · 80 observed 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
2026-09-14 22:38:34	2026-08	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL		RLD	2017-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL		RLD	2017-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL		RLD	2017-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL		RLD	2017-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL		RLD	2017-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL		RLD	2017-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL		RLD	2017-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL		RLD	2017-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL		RLD	2017-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL		RLD	2017-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL		RLD	2017-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL		RLD	2017-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL		RLD	2017-12-19	`87673890dc5c…`

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	N209139-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209139-001	AB	1	`caaa826d4ba7…`

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: PREXXARTAN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALSARTAN	4 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
692a3434-fece-49c6-9b7d-ed7aefc52b50	Product name	3	20260317
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
e7dfdaab-7cf9-4f89-804c-eff5108d94d1	Product name	9	20250305
b6abae2f-ee27-47bc-b150-54dc8d969483	Product name	2	20250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519	Product name	2	20231208
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
f5231d08-c52b-a5a0-ba93-675895c292be	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76281-155-56	PREXXARTAN	20 mL in 1 CUP, UNIT-DOSE	SOLUTION	20	1
76281-155-64	PREXXARTAN	120 mL in 1 BOTTLE	SOLUTION	120	1
76281-155-82	PREXXARTAN	473 mL in 1 BOTTLE	SOLUTION	473	1
76281-155-99	PREXXARTAN	10 in 1 TRAY	SOLUTION	10	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
80M03YXJ7I	VALSARTAN	137862-53-4	VALSARTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1996254	valsartan 20 MG in 5 mL Oral Solution	PSN	508c5de8-9c70-57f5-e063-6394a90af295	1
1996254	valsartan 4 MG/ML Oral Solution	SCD	508c5de8-9c70-57f5-e063-6394a90af295	1
1996254	valsartan 20 MG in 5 mL Oral Solution	SY	508c5de8-9c70-57f5-e063-6394a90af295	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76281-155-56	76281015556	20 mL in 1 CUP, UNIT-DOSE (76281-155-56)	20 ml	2026-05-05	No	No	Current
76281-155-64	76281015564	120 mL in 1 BOTTLE (76281-155-64)	120 ml	2026-05-05	No	No	Current
76281-155-82	76281015582	473 mL in 1 BOTTLE (76281-155-82)	473 ml	2026-05-05	No	No	Current
76281-155-99	76281015599	10 CUP, UNIT-DOSE in 1 TRAY (76281-155-99) / 20 mL in 1 CUP, UNIT-DOSE (76281-155-56)		2026-05-05	No	No	Current