Home NDC 25021-797 Valproate Sodium
Product NDC 25021-797
11-digit product format 250210797
Labeler code 25021
Product ID 25021-797_bac93779-c94f-49e9-90b7-5a53739b47be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valproate Sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA076295
Marketing category ANDA
Marketing start 2024-12-01
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 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 · 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 A076295-001 VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-11-14 caaa826d4ba7…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…
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 2027-12-31 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 25021-797-05 Valproate Sodium 10 in 1 CARTON INJECTION, SOLUTION 10 2 25021-797-05 Valproate Sodium 5 mL in 1 VIAL INJECTION, SOLUTION 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-797 VALPROATE SODIUM INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 1 Current NDC, 2 package rows 20241202_8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 25021-797-05 25021079705 10 VIAL in 1 CARTON (25021-797-05) / 5 mL in 1 VIAL 10 vial 2024-12-01 No No Current