Valproic Acid

Product NDC: 68094-193
11-digit product format: 680940193
Labeler code: 68094
Product ID: 68094-193_2a301501-7348-4640-b5db-bf11f3e4d49e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valproic Acid
Dosage form: SOLUTION
Route: ORAL
Labeler: Precision Dose Inc.
Application: ANDA070868
Marketing category: ANDA
Marketing start: 2003-12-10
Marketing end: 2023-12-31
Substance: VALPROIC ACID
Active strength: 250 mg/5mL
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68094-193		D	Discontinued by firm	2026-08-11
excluded package	package	68094-193	68094-193-58	D	Discontinued by firm	2026-08-11
excluded package	package	68094-193	68094-193-61	D	Discontinued by firm	2026-08-11
excluded package	package	68094-193	68094-193-62	D	Discontinued by firm	2026-08-11

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68094-193-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68094-193-62	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68094-193-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68094-193-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68094-193-62	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68094-193-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68094-193-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68094-193-62	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68094-193-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68094-193-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68094-193-62	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68094-193-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68094-193-61	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68094-193-62	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68094-193-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68094-193-61	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68094-193-62	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68094-193-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68094-193-61	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68094-193-62	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68094-193-58	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68094-193-61	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68094-193-62	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68094-193-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68094-193-61	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68094-193-62	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68094-193-58	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68094-193-61	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68094-193-62	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68094-193-58	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68094-193-61	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68094-193-62	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68094-193-58	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68094-193-61	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68094-193-62	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68094-193-58	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A070868-001	VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP / ORAL			1986-07-01

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	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A070868-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070868-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070868-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070868-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070868-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070868-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070868-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070868-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070868-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070868-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070868-001	AA	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-193-58	ML - Milliliter	68094-193	f261f83c-40e3-4f6e-a87f-6d43813429d1	1	2012-07-24
68094-193-59	ML - Milliliter	68094-193	bb718f36-636b-4ffe-bd8d-beedbede023f	1	2012-07-24
68094-193-61	ML - Milliliter	68094-193	2df99d68-9df0-424d-9314-aa0c9e4d5d0f	1	2012-07-24
68094-193-62	ML - Milliliter	68094-193	cd1bbad2-f1c9-4fc2-bfbc-0b6f37693c23	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Valproic Acid	ACTIVE INGREDIENT	614OI1Z5WI	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
Valproic Acid	ACTIVE MOIETY	614OI1Z5WI	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
alcohol	INACTIVE INGREDIENT	3K9958V90M	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
potassium phosphate, dibasic	INACTIVE INGREDIENT	CI71S98N1Z	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	VALPROIC ACID SOLUTION [PRECISION DOSE INC.]	2

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	Xttrium Laboratories Inc.	3b124a29-30bd-d30e-e063-6294a90ac4ca	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070868 application number: ANDA070868

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
68094-193-61	68094019361	10 TRAY in 1 CASE (68094-193-61) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-193-59)	10 tray	2003-12-10	2023-12-31	No	No	Current
68094-193-62	68094019362	3 TRAY in 1 CASE (68094-193-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-193-59)	3 tray	2003-12-10	2023-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valproic Acid	Precision Dose Inc. \| Morton Grove Pharmaceuticals, Inc.	2023-01-05	HUMAN PRESCRIPTION DRUG LABEL	10
Valproic Acid	A-S Medication Solutions	2018-05-22	HUMAN PRESCRIPTION DRUG LABEL	1