Home NDC 52652-9001 Eprontia
Product NDC 52652-9001
11-digit product format 526529001
Labeler code 52652
Product ID 52652-9001_3feb6452-372c-4c60-8e91-220be75f90b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form SOLUTION
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA214679
Marketing category NDA
Marketing start 2021-12-06
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 1 .
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 N214679-001 EPRONTIA TOPIRAMATE 25MG/ML SOLUTION / ORAL AB RLD, RS 2021-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N214679-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214679-001 11433046 2040-08-21 U-3413 2022-09-13 N214679-001 11433046 2040-08-21 U-3414 2022-09-13 N214679-001 11433046 2040-08-21 U-3415 2022-09-13 N214679-001 11633374 2040-08-21 Drug product 2023-04-27 N214679-001 11826343 2040-08-21 Drug product 2023-12-11 N214679-001 11911362 2040-08-21 U-3413 Drug product 2024-03-12 N214679-001 11911362 2040-08-21 U-3414 Drug product 2024-03-12 N214679-001 11911362 2040-08-21 U-3415 Drug product 2024-03-12 N214679-001 12290503 2040-08-21 U-3413 Drug product 2025-05-16 N214679-001 12290503 2040-08-21 U-3414 Drug product 2025-05-16 N214679-001 12290503 2040-08-21 U-3415 Drug product 2025-05-16
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 2026-02-19 14:30 UTC 2026-02 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL AB RLD, RS 2021-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL AB RLD, RS 2021-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL AB RLD, RS 2021-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL AB RLD, RS 2021-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL AB RLD, RS 2021-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL AB RLD, RS 2021-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL AB RLD, RS 2021-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL AB RLD, RS 2021-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL RLD, RS 2021-11-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214679-001 EPRONTIA 25MG/ML SOLUTION / ORAL AB RLD, RS 2021-11-05 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 174 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214679-001 11433046 2040-08-21 U-3413 2022-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214679-001 11433046 2040-08-21 U-3414 2022-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214679-001 11433046 2040-08-21 U-3415 2022-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214679-001 11633374 2040-08-21 Drug product 2023-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214679-001 11826343 2040-08-21 Drug product 2023-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214679-001 11911362 2040-08-21 U-3413 Drug product 2024-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214679-001 11911362 2040-08-21 U-3414 Drug product 2024-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214679-001 11911362 2040-08-21 U-3415 Drug product 2024-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214679-001 12290503 2040-08-21 U-3413 Drug product 2025-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214679-001 12290503 2040-08-21 U-3415 Drug product 2025-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214679-001 12290503 2040-08-21 U-3414 Drug product 2025-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 11433046 2040-08-21 U-3413 2022-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 11433046 2040-08-21 U-3414 2022-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 11433046 2040-08-21 U-3415 2022-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 11633374 2040-08-21 Drug product 2023-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 11826343 2040-08-21 Drug product 2023-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 11911362 2040-08-21 U-3413 Drug product 2024-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 11911362 2040-08-21 U-3414 Drug product 2024-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 11911362 2040-08-21 U-3415 Drug product 2024-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 12290503 2040-08-21 U-3413 Drug product 2025-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 12290503 2040-08-21 U-3415 Drug product 2025-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214679-001 12290503 2040-08-21 U-3414 Drug product 2025-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214679-001 11433046 2040-08-21 U-3413 2022-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214679-001 11433046 2040-08-21 U-3414 2022-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214679-001 11433046 2040-08-21 U-3415 2022-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214679-001 11633374 2040-08-21 Drug product 2023-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214679-001 11826343 2040-08-21 Drug product 2023-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214679-001 11911362 2040-08-21 U-3413 Drug product 2024-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214679-001 11911362 2040-08-21 U-3414 Drug product 2024-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214679-001 11911362 2040-08-21 U-3415 Drug product 2024-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214679-001 12290503 2040-08-21 U-3413 Drug product 2025-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214679-001 12290503 2040-08-21 U-3415 Drug product 2025-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214679-001 12290503 2040-08-21 U-3414 Drug product 2025-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214679-001 11433046 2040-08-21 U-3413 2022-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214679-001 11433046 2040-08-21 U-3414 2022-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214679-001 11433046 2040-08-21 U-3415 2022-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214679-001 11633374 2040-08-21 Drug product 2023-04-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214679-001 11826343 2040-08-21 Drug product 2023-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214679-001 11911362 2040-08-21 U-3413 Drug product 2024-03-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214679-001 11911362 2040-08-21 U-3414 Drug product 2024-03-12 fd3edfee7708…
Additional Listing Data#
Finished product Yes
Brand name base Eprontia
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2586427 Internal RxNorm lookup 2586433 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 52652-9001-1 Eprontia 473 mL in 1 BOTTLE SOLUTION 473 8 52652-9001-2 Eprontia 1 in 1 CARTON SOLUTION 1 8 52652-9001-2 Eprontia 240 mL in 1 BOTTLE SOLUTION 240 8 52652-9001-3 Eprontia 1 in 1 CARTON SOLUTION 1 8 52652-9001-3 Eprontia 120 mL in 1 BOTTLE SOLUTION 120 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52652-9001 EPRONTIA (TOPIRAMATE) SOLUTION [AZURITY PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 5 package rows 20250323_e2a4df59-fead-4a01-9021-9eda02c48010.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 · 1 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 52652-9001-1 52652900101 473 mL in 1 BOTTLE (52652-9001-1) 473 ml 2021-12-06 0000-00-00 No No Current 52652-9001-2 52652900102 1 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLE 1 bottle 2023-01-02 0000-00-00 No No Current 52652-9001-3 52652900103 1 BOTTLE in 1 CARTON (52652-9001-3) / 120 mL in 1 BOTTLE 1 bottle 2023-01-02 0000-00-00 No No Current