Home NDC 63323-494 Valproate Sodium
Product NDC 63323-494
11-digit product format 633230494
Labeler code 63323
Product ID 63323-494_f09a2148-edd9-4918-8359-7554ed263d3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VALPROATE SODIUM
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA076539
Marketing category ANDA
Marketing start 2003-08-18
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A076539-001 VALPROATE SODIUM VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076539-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076539-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2003-06-26 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Valproate Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALPROATE SODIUM 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5VOM6GYJ0D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1099648 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-494-01 Valproate Sodium 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 11 63323-494-05 Valproate Sodium 10 in 1 TRAY INJECTION, SOLUTION 10 11 63323-494-16 Valproate Sodium 10 in 1 TRAY INJECTION, SOLUTION 10 6 63323-494-41 Valproate Sodium 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALPROATE SODIUM ACTIVE INGREDIENT 5VOM6GYJ0D VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 VALPROIC ACID ACTIVE MOIETY 614OI1Z5WI VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-494 VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20241206_c572ece7-03d3-4c2a-aeb5-61f2023b28ea.zip 63323-494 VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20250202_3dfb6da1-f66a-4618-9f74-d2d6c16c0b58.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-494-01 63323049401 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 63323-494-05 63323049405 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-01) 2003-08-18 0000-00-00 No No Current 63323-494-16 63323049416 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-16) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-41) 2003-08-18 0000-00-00 No No Current 63323-494-41 63323049441 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical