Home NDC 62332-821-31 Divalproex sodium
Product NDC 62332-821
Requested package NDC 62332-821-31
11-digit product format 623320821
Labeler code 62332
Product ID 62332-821_650146da-3899-4750-8c6e-954ddd19f23a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Divalproex sodium
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA218793
Marketing category ANDA
Marketing start 2024-12-23
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 A218793-001 DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218793-001 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 A218793-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-12-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218793-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218793-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218793-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218793-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218793-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218793-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218793-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-12-19 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218793-001 DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-12-19 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 62332-821-10 Divalproex sodium 100 in 1 CARTON CAPSULE, DELAYED RELEASE 100 9 62332-821-10 Divalproex sodium 10 in 1 BLISTER PACK CAPSULE, DELAYED RELEASE 10 9 62332-821-31 Divalproex sodium 100 in 1 BOTTLE CAPSULE, DELAYED RELEASE 100 9 62332-821-71 Divalproex sodium 500 in 1 BOTTLE CAPSULE, DELAYED RELEASE 500 9 62332-821-91 Divalproex sodium 1000 in 1 BOTTLE CAPSULE, DELAYED RELEASE 1000 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-821 DIVALPROEX SODIUM CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS INC.] 7 Current NDC, 5 package rows 20250323_fea19b14-d8ed-4954-bc54-b9240f78b3c3.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 Marketing start Sample Exclude flag Status 62332-821-31 62332082131 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-821-31) 2024-12-23 No No Current