valproic acid

Product NDC: 70518-0730
Requested package NDC: 70518-0730-0
11-digit product format: 705180730
Labeler code: 70518
Product ID: 70518-0730_e21ed5f6-4077-0857-e053-2995a90a0a7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valproic acid
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA073229
Marketing category: ANDA
Marketing start: 2017-09-11
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-0730	70518-0730-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-0730	VALPROIC ACID CAPSULE [REMEDYREPACK INC.]	11	Legacy NDC	20250523_b7872509-f197-4e7a-8248-7dd6d376e408.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0730-0	70518073000	30 CAPSULE in 1 BLISTER PACK (70518-0730-0)	30 capsule	2017-09-11	0000-00-00	No	No	Current