Valproic Acid

Product NDC: 81033-266
Requested package NDC: 81033-266-50
11-digit product format: 810330266
Labeler code: 81033
Product ID: 81033-266_3a214bf4-ea91-0892-e063-6394a90a9a9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valproic Acid
Dosage form: SOLUTION
Route: ORAL
Labeler: Kesin Pharma Corporation
Application: ANDA073178
Marketing category: ANDA
Marketing start: 2024-01-02
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A073178-001	VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA		1992-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A073178-001	AA

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 · 43 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
2026-09-14 22:38:34	2026-08	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1992-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073178-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1992-08-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A073178-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073178-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073178-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073178-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073178-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073178-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073178-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073178-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073178-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073178-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073178-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073178-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073178-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073178-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073178-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073178-001	AA	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A073178-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A073178-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073178-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073178-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073178-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073178-001	AA	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A073178-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Valproic Acid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALPROIC ACID	250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
614OI1Z5WI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099687	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3a2155d0-e79d-3e11-e063-6294a90a4aae	Available on FDA.report

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	SPL version
81033-266-05	Valproic Acid	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	1
81033-266-10	Valproic Acid	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	1
81033-266-50	Valproic Acid	100 in 1 CASE	SOLUTION	100	1
81033-266-52	Valproic Acid	100 in 1 CASE	SOLUTION	100	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-266-05	ML - Milliliter	81033-266	0e918f4b-2558-44b5-bb1a-5f2a18addcf1	1	2025-09-12
81033-266-10	ML - Milliliter	81033-266	4ff50bef-181f-4872-9918-00bb9f24e7f1	1	2025-09-12
81033-266-50	ML - Milliliter	81033-266	e85923ff-6684-4dc2-983d-12e775b40a69	1	2025-09-12
81033-266-52	ML - Milliliter	81033-266	f992c861-18e9-4cd6-8efd-3dd0fd03ae77	1	2025-09-12

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valproic Acid	VALPROIC ACID	REMEDYREPACK INC.	1edd220d-d151-4177-9a29-9fee36489fb7	2026-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073178 application number: ANDA073178
Valproic Acid	VALPROIC ACID	ANI Pharmaceuticals, Inc.	2314af65-b928-42a9-91eb-6372909ab4f5	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073178 application number: ANDA073178
Valproic Acid	VALPROIC ACID	Kesin Pharma Corporation	3a2155d0-e79d-3e11-e063-6294a90a4aae	2025-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073178 application number: ANDA073178 ndc (package): 81033-266-50 ndc (product): 81033-266 ndc11 (package): 81033026650
Valproic Acid	VALPROIC ACID	NorthStar Rx LLC	1286ab49-fa34-488e-e063-6394a90ad582	2024-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073178 application number: ANDA073178

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
1099687	valproic acid 250 MG in 5 mL Oral Solution	PSN	3a2155d0-e79d-3e11-e063-6294a90a4aae	1
1099687	valproic acid 50 MG/ML Oral Solution	SCD	3a2155d0-e79d-3e11-e063-6294a90a4aae	1
1099687	valproate sodium 50 MG/ML Syrup	SY	3a2155d0-e79d-3e11-e063-6294a90a4aae	1
1099687	valproic acid 250 MG per 5 ML Oral Solution	SY	3a2155d0-e79d-3e11-e063-6294a90a4aae	1
1099687	valproic acid 500 MG per 10 ML Oral Solution	SY	3a2155d0-e79d-3e11-e063-6294a90a4aae	1
1099687	VPA 50 MG/ML Oral Solution	SY	3a2155d0-e79d-3e11-e063-6294a90a4aae	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
81033-266-50	81033026650	100 CUP, UNIT-DOSE in 1 CASE (81033-266-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-266-05)	2025-08-01	No	No	Current