Home NDC 31722-181 TOPIRAMATE
Product NDC 31722-181
11-digit product format 317220181
Labeler code 31722
Product ID 31722-181_62911647-4208-47b3-a9af-67f026411019
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA215414
Marketing category ANDA
Marketing start 2021-09-22
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215414-001 TOPIRAMATE TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 A215414-002 TOPIRAMATE TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 A215414-003 TOPIRAMATE TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 A215414-004 TOPIRAMATE TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 · 136 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 2026-08-18 06:07:40 2026-07 A215414-001 TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215414-002 TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215414-003 TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215414-004 TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215414-001 TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215414-002 TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215414-003 TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215414-004 TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215414-001 TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215414-002 TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215414-003 TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215414-004 TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215414-001 TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215414-002 TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215414-003 TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215414-004 TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215414-001 TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215414-002 TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215414-003 TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215414-004 TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215414-001 TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215414-002 TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215414-003 TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215414-004 TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215414-001 TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215414-002 TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215414-003 TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215414-004 TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215414-001 TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215414-002 TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215414-003 TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215414-004 TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215414-001 TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215414-002 TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215414-003 TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215414-004 TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215414-001 TOPIRAMATE 25MG TABLET / ORAL AB 2021-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215414-002 TOPIRAMATE 50MG TABLET / ORAL AB 2021-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215414-003 TOPIRAMATE 100MG TABLET / ORAL AB 2021-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215414-004 TOPIRAMATE 200MG TABLET / ORAL AB 2021-08-26 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 136 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TOPIRAMATE
Listing expiration 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 151226 Internal RxNorm lookup 199888 Internal RxNorm lookup 199889 Internal RxNorm lookup 199890 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 31722-181-05 TOPIRAMATE 500 in 1 BOTTLE TABLET 500 3 31722-181-60 TOPIRAMATE 60 in 1 BOTTLE TABLET 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-181 TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20230928_cefbc5f4-ef5f-4732-ab96-a69a183f0b6b.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 Units Marketing start Marketing end Sample Exclude flag Status 31722-181-05 31722018105 500 TABLET in 1 BOTTLE (31722-181-05) 500 tablet 2021-09-22 0000-00-00 No No Current 31722-181-60 31722018160 60 TABLET in 1 BOTTLE (31722-181-60) 60 tablet 2021-09-22 0000-00-00 No No Current