VALPROIC ACID

Product NDC: 72189-267
Requested package NDC: 72189-267-30
11-digit product format: 721890267
Labeler code: 72189
Product ID: 72189-267_cc1e3db1-1345-59df-e053-2995a90a8ffc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VALPROIC ACID
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA207611
Marketing category: ANDA
Marketing start: 2021-09-16
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: 2022-12-31
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	72189-267	72189-267-30	D	Discontinued by firm		2026-08-10

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A207611-001	VALPROIC ACID	VALPROIC ACID	250MG	CAPSULE / ORAL			2019-08-05

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.

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	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	2019-08-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	2019-08-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	2019-08-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	2019-08-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	2019-08-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	2019-08-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	2019-08-05	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL	BX	2019-08-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207611-001	VALPROIC ACID	250MG	CAPSULE / ORAL		2019-08-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207611-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207611-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207611-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207611-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207611-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207611-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207611-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207611-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207611-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207611-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207611-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207611-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207611-001	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207611-001	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207611-001	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207611-001	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207611-001	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207611-001	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207611-001	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207611-001	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207611-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207611-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207611-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207611-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207611-001	BX	1	`cb3db0bc1861…`

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
72189-267-30	2025-06-06	C162847	48780-1	1030e365-63ea-111a-e063-dadaa90a10e2	Valproic Acid
72189-267-30	2025-01-30	C162847	48780-1	1030e365-63ea-111a-e063-dadaa90a10e2	Valproic Acid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-267-30	VALPROIC ACID	30 in 1 BOTTLE	CAPSULE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-267-30	EA - Each	72189-267	de6ee8d4-99f8-4ddc-b9f2-6dca6ce0e928	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-267	VALPROIC ACID CAPSULE VALPROIC ACID CAPSULE [DIRECT_RX]	2	Legacy NDC, 1 package rows	20210918_8bdbacb1-b38a-3282-e053-2a95a90af022.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valproic Acid	VALPROIC ACID	Direct_Rx	8bdbacb1-b38a-3282-e053-2a95a90af022	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 72189-267-30 ndc (product): 72189-267 ndc11 (package): 72189026730

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	8bdbacb1-b38a-3282-e053-2a95a90af022	3
1099681	valproic acid 250 MG Oral Capsule	SCD	8bdbacb1-b38a-3282-e053-2a95a90af022	3
1099681	VPA 250 MG Oral Capsule	SY	8bdbacb1-b38a-3282-e053-2a95a90af022	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-267-30	72189026730	30 CAPSULE in 1 BOTTLE (72189-267-30)	30 capsule	2021-09-16	0000-00-00	No	No	Current