valproic acid

Product NDC: 0832-0310
11-digit product format: 008320310
Labeler code: 0832
Product ID: 0832-0310_39829040-e2d4-f4ca-e063-6394a90ace84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valproic acid
Dosage form: CAPSULE
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA073229
Marketing category: ANDA
Marketing start: 2011-10-29
Marketing end: 2027-03-31
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
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
A073229-001	VALPROIC ACID	VALPROIC ACID	250MG	CAPSULE / ORAL	AB		1991-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073229-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`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	A073229-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073229-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073229-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073229-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073229-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073229-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073229-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073229-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073229-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073229-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073229-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073229-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073229-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073229-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073229-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073229-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073229-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073229-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073229-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073229-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073229-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073229-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073229-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073229-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073229-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073229-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073229-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073229-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073229-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073229-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073229-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073229-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073229-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073229-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073229-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073229-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073229-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073229-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073229-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073229-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: valproic acid

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
7d4df6ad-3d53-4664-9200-749487bf3689	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	Strength	SPL version
0832-0310-11	valproic acid	100 in 1 BOTTLE	CAPSULE	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0832-0310-11	EA - Each	0832-0310	75c559d9-a7c6-45d8-94ff-c883e910fc1a	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
valproic acid	ACTIVE INGREDIENT	614OI1Z5WI	VALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]	2
valproic acid	ACTIVE MOIETY	614OI1Z5WI	VALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	VALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	VALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]	2
peanut oil	INACTIVE INGREDIENT	5TL50QU0W4	VALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	VALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0832-0310	VALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, LLC]	12	Current NDC, Legacy NDC, 1 package rows	20230420_7d4df6ad-3d53-4664-9200-749487bf3689.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valproic	VALPROIC ACID	Actavis Pharma, Inc.	cef3e335-5891-412f-89c4-79fcd2f145b7	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073229 application number: ANDA073229
valproic acid	VALPROIC ACID	Upsher-Smith Laboratories, LLC	7d4df6ad-3d53-4664-9200-749487bf3689	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073229 application number: ANDA073229 ndc (product): 0832-0310
Valproic	VALPROIC ACID	Aphena Pharma Solutions - Tennessee, LLC	34a0d45a-4388-7d8b-e063-6394a90a6c3f	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073229 application number: ANDA073229
Valproic Acid	VALPROIC ACID	Direct_Rx	8bdbacb1-b38a-3282-e053-2a95a90af022	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073229 application number: ANDA073229
valproic acid	VALPROIC ACID	Aphena Pharma Solutions - Tennessee, LLC	3904177b-8a26-4356-9080-d2a2e3f468af	2017-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073229 application number: ANDA073229

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	7d4df6ad-3d53-4664-9200-749487bf3689	13
1099681	valproic acid 250 MG Oral Capsule	SCD	7d4df6ad-3d53-4664-9200-749487bf3689	13
1099681	VPA 250 MG Oral Capsule	SY	7d4df6ad-3d53-4664-9200-749487bf3689	13
1099681	valproic acid 250 MG Oral Capsule	PSN	3904177b-8a26-4356-9080-d2a2e3f468af	3
1099681	valproic acid 250 MG Oral Capsule	PSN	8bdbacb1-b38a-3282-e053-2a95a90af022	3
1099681	valproic acid 250 MG Oral Capsule	SCD	3904177b-8a26-4356-9080-d2a2e3f468af	3
1099681	valproic acid 250 MG Oral Capsule	SCD	8bdbacb1-b38a-3282-e053-2a95a90af022	3
1099681	VPA 250 MG Oral Capsule	SY	3904177b-8a26-4356-9080-d2a2e3f468af	3
1099681	VPA 250 MG Oral Capsule	SY	8bdbacb1-b38a-3282-e053-2a95a90af022	3
1099681	valproic acid 250 MG Oral Capsule	PSN	df742f4a-9440-538d-e053-2a95a90a1de6	1
1099681	valproic acid 250 MG Oral Capsule	SCD	df742f4a-9440-538d-e053-2a95a90a1de6	1
1099681	VPA 250 MG Oral Capsule	SY	df742f4a-9440-538d-e053-2a95a90a1de6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0832-0310-11	00832031011	100 CAPSULE in 1 BOTTLE (0832-0310-11)	100 capsule	2015-02-09	2027-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
valproic acid	REMEDYREPACK INC.	2025-08-15	HUMAN PRESCRIPTION DRUG LABEL	13
valproic acid	Upsher-Smith Laboratories, LLC \| Catalent Pharma Solutions	2025-07-09	HUMAN PRESCRIPTION DRUG LABEL	13
Valproic Acid	Direct_Rx	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
valproic acid	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	15
Valproic Acid	NuCare Pharmaceuticals,Inc.	2022-05-20	HUMAN PRESCRIPTION DRUG LABEL	1
valproic acid	Aphena Pharma Solutions - Tennessee, LLC	2017-10-17	HUMAN PRESCRIPTION DRUG LABEL	3