VALPROIC ACID

Product NDC: 0121-1350
11-digit product format: 001211350
Labeler code: 0121
Product ID: 0121-1350_8c4404f6-81d2-4211-b6b9-5e8d1f497dd6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VALPROIC ACID
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA075379
Marketing category: ANDA
Marketing start: 2005-04-11
Substance: VALPROIC ACID
Active strength: 500 mg/10mL
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 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
A075379-001	VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075379-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA		2000-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075379-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075379-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075379-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075379-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075379-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075379-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075379-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075379-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075379-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075379-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075379-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075379-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075379-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075379-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075379-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075379-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075379-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075379-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075379-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075379-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075379-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075379-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075379-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075379-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075379-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075379-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075379-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075379-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075379-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075379-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075379-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075379-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075379-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075379-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075379-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075379-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075379-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075379-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075379-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075379-001	AA	1	`cb3db0bc1861…`

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	500 mg/10mL

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
7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	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
0121-1350-00	VALPROIC ACID	10 in 1 TRAY	SOLUTION	10	21
0121-1350-00	VALPROIC ACID	10 in 1 CASE	SOLUTION	10	21
0121-1350-10	VALPROIC ACID	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1350-00	ML - Milliliter	0121-1350	bcb803af-b926-4cc6-ad91-c2aebc5929f3	1	2017-08-11
0121-1350-10	ML - Milliliter	0121-1350	5a87d0bc-c4de-48b0-9af8-cd1bb9a21ea0	1	2017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALPROIC ACID	ACTIVE INGREDIENT	614OI1Z5WI	VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	6
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	6
SORBITOL	INACTIVE INGREDIENT	506T60A25R	VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-1350	VALPROIC ACID SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	21	Current NDC, Legacy NDC, 3 package rows	20250205_7d5cb52e-37dd-4dfa-a6f4-09f9548846c6.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VALPROIC ACID	VALPROIC ACID	American Health Packaging	4b619f73-44e5-4a99-b425-a96cb2228c87	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379
VALPROIC ACID	VALPROIC ACID	REMEDYREPACK INC.	65c1589e-c591-4b79-b75e-884c0d609ae8	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379
VALPROIC ACID	VALPROIC ACID	Major Pharmaceuticals	a33f7657-ad0f-43e9-ba48-024746e6d08e	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379
VALPROIC ACID	VALPROIC ACID	PAI Holdings, LLC dba PAI Pharma	7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	2025-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379 ndc (product): 0121-1350
VALPROIC ACID	VALPROIC ACID	Bryant Ranch Prepack	db53c5aa-d7a5-49ba-8227-c2d67ced23e2	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379

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	7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	21
1099687	valproic acid 50 MG/ML Oral Solution	SCD	7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	21
1099687	valproate sodium 50 MG/ML Syrup	SY	7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	21
1099687	valproic acid 250 MG per 5 ML Oral Solution	SY	7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	21
1099687	valproic acid 500 MG per 10 ML Oral Solution	SY	7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	21
1099687	VPA 50 MG/ML Oral Solution	SY	7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-1350-00	00121135000	10 TRAY in 1 CASE (0121-1350-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1350-10)	10 tray	2005-04-11	0000-00-00	No	No	Current
0121-1350-10	00121135010	10 mL in 1 CUP, UNIT-DOSE	10 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VALPROIC ACID	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2025-01-24	HUMAN PRESCRIPTION DRUG LABEL	21