Valproate Sodium

Product NDC: 70860-784
11-digit product format: 708600784
Labeler code: 70860
Product ID: 70860-784_37440743-cd78-454a-8d6e-305376ec8bd4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valproate sodium
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA076295
Marketing category: ANDA
Marketing start: 2022-11-01
Marketing end: 0000-00-00
Substance: VALPROATE SODIUM
Active strength: 100 mg/mL
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70860-784		D	Discontinued by firm		2026-08-07
excluded package	package	70860-784	70860-784-05	D	Discontinued by firm		2026-08-07

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
A076295-001	VALPROATE SODIUM	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP		2002-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076295-001	AP

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	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076295-001	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2002-11-14	`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	A076295-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076295-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076295-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076295-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076295-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076295-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076295-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076295-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076295-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076295-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076295-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076295-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076295-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076295-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076295-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076295-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076295-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076295-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076295-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076295-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076295-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076295-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076295-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076295-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076295-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076295-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076295-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076295-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076295-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076295-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076295-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076295-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076295-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076295-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076295-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076295-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076295-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076295-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076295-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076295-001	AP	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70860-784-05	2024-03-05	C162847	48780-1	1030e365-44fe-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VALPROATE SODIUM INJECTION safely and effectively. See full prescribing information for VALPROATE SODIUM INJECTION. VALPROATE SODIUM injection for intravenous injection Initial U.S. Approval: 1996
70860-784-05	2024-01-30	C162847	48780-1	1030e365-44fe-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VALPROATE SODIUM INJECTION safely and effectively. See full prescribing information for VALPROATE SODIUM INJECTION. VALPROATE SODIUM injection for intravenous injection Initial U.S. Approval: 1996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-784-05	ML - Milliliter	70860-784	241b5347-b23f-4cb5-abe6-6c4b06e9ab61	1	2023-04-07
70860-784-41	ML - Milliliter	70860-784	19ea9dc6-caba-405b-89d4-73725d4b774b	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70860-784	VALPROATE SODIUM INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]	3	Legacy NDC	20250130_856ecdad-a8e0-4bda-a217-cd7948ddfa59.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
Valproate Sodium	VALPROATE SODIUM	Sagent Pharmaceuticals	8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076295 application number: ANDA076295

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5VOM6GYJ0D	VALPROATE SODIUM	1069-66-5	VALPROATE SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-784-05	70860078405	10 VIAL, SINGLE-DOSE in 1 CARTON (70860-784-05) > 5 mL in 1 VIAL, SINGLE-DOSE (70860-784-41)	2022-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valproate Sodium	Athenex Pharmaceutical Division, LLC.	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	3