Home NDC 0121-0892 Phenytoin
Product NDC 0121-0892
11-digit product format 001210892
Labeler code 0121
Product ID 0121-0892_4daa397f-237b-4327-91bd-d86b19e4b9b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form SUSPENSION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA040521
Marketing category ANDA
Marketing start 2004-04-08
Substance PHENYTOIN
Active strength 125 mg/5mL
Pharmacologic classes Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A 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 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 A040521-001 PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040521-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Phenytoin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYTOIN 125 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6158TKW0C5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1313112 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 0121-0892-63 Phenytoin 4 mL in 1 CUP, UNIT-DOSE SUSPENSION 4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0892 PHENYTOIN SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] 4 Current NDC, Legacy NDC, 1 package rows 20241121_f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15.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 · 4 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 0121-0892-50 00121089250 5 TRAY in 1 CASE (0121-0892-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 4 mL in 1 CUP, UNIT-DOSE (0121-0892-63) 5 tray 2020-03-26 0000-00-00 No No Current 0121-0892-63 00121089263 4 mL in 1 CUP, UNIT-DOSE (0121-0892-63) 4 ml 2004-04-08 No No Current