VALPROIC ACID

Product NDC: 0904-7621
Requested package NDC: 0904-7621-72
11-digit product format: 009047621
Labeler code: 0904
Product ID: 0904-7621_3aea592e-0fb0-4853-83d1-41b2d13c5302
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VALPROIC ACID
Dosage form: SOLUTION
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA075379
Marketing category: ANDA
Marketing start: 2026-08-03
Substance: VALPROIC ACID
Active strength: 500 mg/10mL
Pharmacologic classes: Anti-epileptic Agent [EPC]; Decreased Central Nervous System Disorganized Electrical Activity [PE]; Mood Stabilizer [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075379-001	VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075379-001	AA

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA		2000-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075379-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075379-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075379-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075379-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075379-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075379-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075379-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075379-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075379-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075379-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075379-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075379-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075379-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075379-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075379-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075379-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075379-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075379-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075379-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075379-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075379-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075379-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075379-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075379-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075379-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075379-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075379-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075379-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075379-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075379-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075379-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075379-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075379-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075379-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075379-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075379-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075379-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075379-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075379-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075379-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALPROIC ACID	500 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
614OI1Z5WI	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a33f7657-ad0f-43e9-ba48-024746e6d08e	Available on FDA.report

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
VALPROIC ACID	VALPROIC ACID	American Health Packaging	4b619f73-44e5-4a99-b425-a96cb2228c87	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379
VALPROIC ACID	VALPROIC ACID	REMEDYREPACK INC.	65c1589e-c591-4b79-b75e-884c0d609ae8	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379
VALPROIC ACID	VALPROIC ACID	PAI Holdings, LLC dba PAI Pharma	7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	2025-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379
VALPROIC ACID	VALPROIC ACID	Bryant Ranch Prepack	db53c5aa-d7a5-49ba-8227-c2d67ced23e2	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
614OI1Z5WI	VALPROIC ACID	99-66-1	VALPROIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
0904-7621-72	00904762172	10 TRAY in 1 CASE (0904-7621-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7621-66)	10 tray	2026-08-03	0	Current