Valproic

Product NDC: 71610-906
11-digit product format: 716100906
Labeler code: 71610
Product ID: 71610-906_35d13593-172f-3a08-e063-6294a90a72fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valproic Acid
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA073229
Marketing category: ANDA
Marketing start: 2009-09-08
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 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
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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073229-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Valproic
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
34a0d45a-4388-7d8b-e063-6394a90a6c3f	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
71610-906-30	Valproic	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30	2
71610-906-53	Valproic	60 in 1 BOTTLE	CAPSULE, LIQUID FILLED	60	2
71610-906-60	Valproic	90 in 1 BOTTLE	CAPSULE, LIQUID FILLED	90	2
71610-906-70	Valproic	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120	2
71610-906-80	Valproic	180 in 1 BOTTLE	CAPSULE, LIQUID FILLED	180	2
71610-906-90	Valproic	240 in 1 BOTTLE	CAPSULE, LIQUID FILLED	240	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-906-30	EA - Each	71610-906	e1b6e180-fc42-4594-a5c6-b34d2e637c6a	1	2025-06-13
71610-906-53	EA - Each	71610-906	8cd735fd-bbc3-4a72-8568-514b99aada4e	1	2025-06-13
71610-906-60	EA - Each	71610-906	dbb25ea3-429b-4825-a379-3afe9f4d4f73	1	2025-06-13
71610-906-70	EA - Each	71610-906	f19b7400-3d6f-4c57-8b76-1399b98378e2	1	2025-07-08
71610-906-80	EA - Each	71610-906	46def0a9-a200-430f-bb6f-cbc7d293e3c4	1	2025-06-13
71610-906-90	EA - Each	71610-906	038e050a-6775-400a-95a6-832139e53ba5	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-906	VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]	2	Current NDC, 6 package rows	20250529_34a0d45a-4388-7d8b-e063-6394a90a6c3f.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
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 ndc (product): 71610-906
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	34a0d45a-4388-7d8b-e063-6394a90a6c3f	2
1099681	valproic acid 250 MG Oral Capsule	SCD	34a0d45a-4388-7d8b-e063-6394a90a6c3f	2
1099681	VPA 250 MG Oral Capsule	SY	34a0d45a-4388-7d8b-e063-6394a90a6c3f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-906-30	71610090630	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-30)	2025-05-07	No	No	Current
71610-906-53	71610090653	60 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-53)	2025-05-07	No	No	Current
71610-906-60	71610090660	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-60)	2025-05-07	No	No	Current
71610-906-70	71610090670	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-70)	2025-05-23	No	No	Current
71610-906-80	71610090680	180 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-80)	2025-05-07	No	No	Current
71610-906-90	71610090690	240 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-90)	2025-05-23	No	No	Current