Home NDC 50268-816 Zonisamide
Product NDC 50268-816
11-digit product format 502680816
Labeler code 50268
Product ID 50268-816_41ac7d6a-8113-6e97-e063-6394a90a088b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zonisamide
Dosage form CAPSULE
Route ORAL
Labeler AvPAK
Application ANDA077869
Marketing category ANDA
Marketing start 2014-07-02
Substance ZONISAMIDE
Active strength 100 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]
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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077869-001 ZONISAMIDE ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 A077869-002 ZONISAMIDE ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 A077869-003 ZONISAMIDE ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077869-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077869-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077869-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-05-31 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
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 Zonisamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZONISAMIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 459384H98V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314285 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 50268-816-11 Zonisamide 1 in 1 BLISTER PACK CAPSULE 1 10 50268-816-15 Zonisamide 50 in 1 BOX CAPSULE 50 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-816 ZONISAMIDE CAPSULE [AVPAK] 9 Current NDC, Legacy NDC, 2 package rows 20250112_b20a51ef-255e-1eb0-c0e1-461cde46b887.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 · 5 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 50268-816-11 50268081611 1 in 1 BLISTER PACK Historical 50268-816-15 50268081615 50 BLISTER PACK in 1 BOX (50268-816-15) / 1 CAPSULE in 1 BLISTER PACK (50268-816-11) 50 blister pack 2014-07-02 0000-00-00 No No Current