Valproic Acid

Product NDC: 67046-808
Requested package NDC: 67046-808-30
11-digit product format: 670460808
Labeler code: 67046
Product ID: 67046-808_597a6144-324c-9533-e053-2991aa0ab896
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valproic Acid
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA073484
Marketing category: ANDA
Marketing start: 2016-07-15
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: 2020-12-31
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	67046-808	67046-808-30	I	Inactivated by FDA		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 · 18 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67046-808-30	2022-01-28	C162847	48780-1	d6a99b39-9c94-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use VALPROIC ACID CAPSULES safely and effectively. See full prescribing information for VALPROIC ACID CAPSULES. VALPROIC ACID capsules, USP for oral use 808 Initial U.S. Approval: 1978

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-808-30	Valproic Acid	30 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-808	VALPROIC ACID CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 1 package rows	20170918_597a6144-324b-9533-e053-2991aa0ab896.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

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	597a6144-324b-9533-e053-2991aa0ab896	1
1099681	valproic acid 250 MG Oral Capsule	SCD	597a6144-324b-9533-e053-2991aa0ab896	1
1099681	VPA 250 MG Oral Capsule	SY	597a6144-324b-9533-e053-2991aa0ab896	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67046-808-30	67046080830	30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67046-808-30)	2017-09-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valproic Acid	Contract Pharmacy Services-PA \| Coupler Enterprises	2017-09-18	HUMAN PRESCRIPTION DRUG LABEL	1