Home NDC 70518-4247 topiramate
Product NDC 70518-4247
11-digit product format 705184247
Labeler code 70518
Product ID 70518-4247_5a6ebf1d-5715-0a6b-e063-6394a90aeb8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topiramate
Dosage form CAPSULE, COATED PELLETS
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA078877
Marketing category ANDA
Marketing start 2024-12-24
Substance TOPIRAMATE
Active strength 25 mg/1
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078877-001 TOPIRAMATE TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 A078877-002 TOPIRAMATE TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 A078877-003 TOPIRAMATE TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23
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 3 · 97 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 2026-09-14 22:38:34 2026-08 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL 2024-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL 2024-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL 2024-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL 2024-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL 2024-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 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 topiramate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 25 mg/1
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 205315 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 70518-4247-0 topiramate 30 in 1 BOX CAPSULE, COATED PELLETS 30 3 70518-4247-1 topiramate 1 in 1 POUCH CAPSULE, COATED PELLETS 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4247 TOPIRAMATE CAPSULE, COATED PELLETS [REMEDYREPACK INC.] 1 Current NDC, 2 package rows 20250101_0c0a6774-e234-47a5-866e-462cfd99744c.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 · 3 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 70518-4247-0 70518424700 30 POUCH in 1 BOX (70518-4247-0) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-4247-1) 30 pouch 2024-12-24 No No Current 70518-4247-1 70518424701 1 in 1 POUCH Historical