Valproic Acid

Product NDC: 43353-279
11-digit product format: 433530279
Labeler code: 43353
Product ID: 43353-279_1f5efbea-ccd0-4213-9324-769b0077144f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valproic Acid
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA073484
Marketing category: ANDA
Marketing start: 2016-07-15
Substance: VALPROIC ACID
Active strength: 250 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
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 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
A073484-001	VALPROIC ACID	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073484-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB		1993-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB		1993-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073484-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	RS	1993-06-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A073484-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073484-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073484-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073484-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073484-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073484-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073484-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073484-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073484-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073484-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073484-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073484-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073484-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073484-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073484-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073484-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073484-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073484-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073484-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073484-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073484-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073484-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073484-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073484-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073484-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073484-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073484-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073484-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073484-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073484-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073484-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073484-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073484-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073484-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073484-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073484-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073484-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073484-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073484-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073484-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALPROIC ACID	250 mg/1

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099681	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
3798f957-8b32-4ac0-8fd1-80283414c255	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b10a892b-b985-4cbc-9547-9ac4b72b784f	Product name	2	20250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69	Product name	7	20250624
57fc3d01-4737-4091-9728-9e8a4c9e708d	Product name	1	20200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645	Product name	1	20140508
97fce1a8-50c4-f088-0e31-64d82b6e9081	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-279-53	Valproic Acid	60 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	60	2
43353-279-60	Valproic Acid	90 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	90	2
43353-279-70	Valproic Acid	120 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	120	2
43353-279-80	Valproic Acid	180 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	180	2
43353-279-90	Valproic Acid	240 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	240	2
43353-279-94	Valproic Acid	360 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	360	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-279-53	EA - Each	43353-279	e0c4474c-05bf-452a-b31f-b8df03ed0cc4	1	2017-11-06
43353-279-60	EA - Each	43353-279	b22579ab-b213-4d0f-87ab-63dd16e261d3	1	2017-11-06
43353-279-70	EA - Each	43353-279	4aa207a3-c780-4904-b333-115e66332fe2	1	2017-11-06
43353-279-80	EA - Each	43353-279	97fc9357-f508-493a-9177-24a3e3078ddc	1	2017-11-06
43353-279-90	EA - Each	43353-279	074ec88f-7fcb-485f-93fb-7acf21a9c421	1	2017-11-06
43353-279-94	EA - Each	43353-279	8142e08a-de4f-4b6d-bc28-58b315908250	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-279	VALPROIC ACID CAPSULE, LIQUID FILLED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 6 package rows	20171021_3798f957-8b32-4ac0-8fd1-80283414c255.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valproic Acid	VALPROIC ACID	Bionpharma Inc.	ceb52870-76d0-4108-a1d4-ba7096fbacdd	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073484 application number: ANDA073484
Valproic Acid	VALPROIC ACID	REMEDYREPACK INC.	ec41025a-ed7d-48c8-9005-08e3a9417f30	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073484 application number: ANDA073484
Valproic Acid	VALPROIC ACID	ATLANTIC BIOLOGICALS CORP.	453444b6-1f50-49de-ab3c-1e429c83bffa	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073484 application number: ANDA073484
Valproic Acid	VALPROIC ACID	NCS HealthCare of KY, LLC dba Vangard Labs	8785a152-3010-4370-aaf5-11315a1a56e1	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073484 application number: ANDA073484
Valproic Acid	VALPROIC ACID	Bryant Ranch Prepack	a9cef1ec-ba52-4849-8889-87898d6f4199	2025-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073484 application number: ANDA073484
Valproic Acid	VALPROIC ACID	Aphena Pharma Solutions - Tennessee, LLC	3798f957-8b32-4ac0-8fd1-80283414c255	2017-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073484 application number: ANDA073484 ndc (product): 43353-279

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1099681	valproic acid 250 MG Oral Capsule	PSN	3798f957-8b32-4ac0-8fd1-80283414c255	2
1099681	valproic acid 250 MG Oral Capsule	SCD	3798f957-8b32-4ac0-8fd1-80283414c255	2
1099681	VPA 250 MG Oral Capsule	SY	3798f957-8b32-4ac0-8fd1-80283414c255	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-279-53	43353027953	60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-53)	2017-02-11	0000-00-00	No	No	Current
43353-279-60	43353027960	90 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-60)	2017-02-11	0000-00-00	No	No	Current
43353-279-70	43353027970	120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-70)	2017-02-16	0000-00-00	No	No	Current
43353-279-80	43353027980	180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-80)	2017-02-11	0000-00-00	No	No	Current
43353-279-90	43353027990	240 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-90)	2017-04-25	0000-00-00	No	No	Current
43353-279-94	43353027994	360 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-94)	2017-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valproic Acid	Aphena Pharma Solutions - Tennessee, LLC	2017-10-17	HUMAN PRESCRIPTION DRUG LABEL	2