Valproic acid

Product NDC: 63739-253
11-digit product format: 637390253
Labeler code: 63739
Product ID: 63739-253_6e5ca6ac-75ca-4a53-92ab-995dff1f6672
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valproic acid
Dosage form: CAPSULE
Route: ORAL
Labeler: McKesson Corporation dba SKY Packaging
Application: ANDA207611
Marketing category: ANDA
Marketing start: 2020-02-21
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: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63739-253		I	Inactivated by FDA		2026-08-10
excluded package	package	63739-253	63739-253-40	I	Inactivated by FDA		2026-08-10

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63739-253-40	Valproic acid	100 in 1 BOTTLE	CAPSULE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-253-40	EA - Each	63739-253	a1762b0a-fec7-4d82-9d9b-b5f4b07b4e54	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-253	VALPROIC ACID CAPSULE [MCKESSON CORPORATION DBA SKY PACKAGING]	1	Legacy NDC, 1 package rows	20200607_82d29262-c72b-48d1-8471-5d582b3496ea.zip

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	82d29262-c72b-48d1-8471-5d582b3496ea	1
1099681	valproic acid 250 MG Oral Capsule	SCD	82d29262-c72b-48d1-8471-5d582b3496ea	1
1099681	VPA 250 MG Oral Capsule	SY	82d29262-c72b-48d1-8471-5d582b3496ea	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-253-40	63739025340	100 CAPSULE in 1 BOTTLE (63739-253-40)	100 capsule	2020-02-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valproic acid	McKesson Corporation dba SKY Packaging \| Softech Pharma Pvt. Ltd.	2020-05-22	Human Prescription Drug Label	1