Home NDC 0121-0670 ETHOSUXIMIDE
Product NDC 0121-0670
11-digit product format 001210670
Labeler code 0121
Product ID 0121-0670_14d8b71e-abd8-49d4-b4cc-82880e54db8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ETHOSUXIMIDE
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA040253
Marketing category ANDA
Marketing start 2000-11-22
Substance ETHOSUXIMIDE
Active strength 250 mg/5mL
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 42 .
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 A040253-001 ETHOSUXIMIDE ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040253-001 AA
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 2 · 42 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 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040253-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2000-11-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ETHOSUXIMIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHOSUXIMIDE 250 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5SEH9X1D1D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 251322 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 0121-0670-16 ETHOSUXIMIDE 473 mL in 1 BOTTLE SOLUTION 473 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHOSUXIMIDE ACTIVE INGREDIENT 5SEH9X1D1D ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 ETHOSUXIMIDE ACTIVE MOIETY 5SEH9X1D1D ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0670 ETHOSUXIMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 16 Current NDC, Legacy NDC, 1 package rows 20250326_8a5cc930-0b36-48a8-9ad0-de633b208742.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 0121-0670-16 00121067016 473 mL in 1 BOTTLE (0121-0670-16) 473 ml 2000-11-22 0000-00-00 No No Current