Home NDC 70756-447-12 divalproex sodium
Product NDC 70756-447
Requested package NDC 70756-447-12
11-digit product format 707560447
Labeler code 70756
Product ID 70756-447_7cdbbe7f-37c2-41c5-87c1-93882fa42865
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name divalproex sodium
Dosage form CAPSULE, COATED PELLETS
Route ORAL
Labeler Lifestar Pharma LLC
Application ANDA217358
Marketing category ANDA
Marketing start 2025-08-12
Substance DIVALPROEX SODIUM
Active strength 125 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A217358-001 DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2025-08-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217358-001 AB
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.
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 2026-09-14 22:38:34 2026-08 A217358-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2025-08-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217358-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2025-08-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217358-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2025-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217358-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2025-08-12 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217358-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2025-08-12 a50c72e98297…
Observed Orange Book normalized TE history# 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 divalproex sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIVALPROEX SODIUM 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 644VL95AO6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1099596 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 70756-447-11 divalproex sodium 100 in 1 BOTTLE CAPSULE, COATED PELLETS 100 6 70756-447-12 divalproex sodium 1000 in 1 BOTTLE CAPSULE, COATED PELLETS 1000 6 70756-447-30 divalproex sodium 30 in 1 BOTTLE CAPSULE, COATED PELLETS 30 6 70756-447-51 divalproex sodium 500 in 1 BOTTLE CAPSULE, COATED PELLETS 500 6
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 Marketing start Sample Exclude flag Status 70756-447-12 70756044712 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-12) 2025-08-12 No No Current