Home NDC 70954-228 Methsuximide
Product NDC 70954-228
11-digit product format 709540228
Labeler code 70954
Product ID 70954-228_5138e347-665b-4dd6-b9f8-12f4a807ed4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methsuximide
Dosage form CAPSULE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA217213
Marketing category ANDA
Marketing start 2023-05-01
Substance METHSUXIMIDE
Active strength 300 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], 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 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 A217213-001 METHSUXIMIDE METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217213-001 AB
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 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217213-001 METHSUXIMIDE 300MG CAPSULE / ORAL AB 2023-05-01 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 2023-12-20 04:57 UTC 2023-12 A217213-001 CGT 2023-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217213-001 CGT 2023-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217213-001 CGT 2023-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217213-001 CGT 2023-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217213-001 CGT 2023-10-28 3f0d92c62455…
Additional Listing Data#
Finished product Yes
Brand name base Methsuximide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHSUXIMIDE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0G76K8X6C0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197949 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 70954-228-10 Methsuximide 100 in 1 BOTTLE CAPSULE 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-228 METHSUXIMIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20230504_5138e347-665b-4dd6-b9f8-12f4a807ed4e.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 Sample Exclude flag Status 70954-228-10 70954022810 100 CAPSULE in 1 BOTTLE (70954-228-10) 100 capsule 2023-05-01 No No Current