Home NDC 81033-035 TOPIRAMATE
Product NDC 81033-035
11-digit product format 810330035
Labeler code 81033
Product ID 81033-035_54636499-ba0d-daf9-e063-6394a90a0966
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOPIRAMATE
Dosage form SOLUTION
Route ORAL
Labeler Kesin Pharma
Application ANDA217795
Marketing category ANDA
Marketing start 2025-07-07
Substance TOPIRAMATE
Active strength 25 mg/mL
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
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 A217795-001 TOPIRAMATE TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217795-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A217795-001 PC 2026-01-05
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 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217795-001 TOPIRAMATE 25MG/ML SOLUTION / ORAL AB 2024-10-31 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A217795-001 PC 2026-01-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217795-001 PC 2026-01-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217795-001 PC 2026-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217795-001 PC 2026-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217795-001 PC 2026-01-05 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217795-001 PC 2026-01-05 a50c72e98297…
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 TOPIRAMATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0H73WJJ391 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2586427 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 81033-035-14 81033003514 10 CUP, UNIT-DOSE in 1 CARTON (81033-035-14) / 4 mL in 1 CUP, UNIT-DOSE (81033-035-04) 2026-07-01 No No Current 81033-035-15 81033003515 10 CUP, UNIT-DOSE in 1 CARTON (81033-035-15) / 6 mL in 1 CUP, UNIT-DOSE (81033-035-06) 2026-07-01 No No Current 81033-035-16 81033003516 10 CUP, UNIT-DOSE in 1 CARTON (81033-035-16) / 8 mL in 1 CUP, UNIT-DOSE (81033-035-08) 2026-07-01 No No Current