Home NDC 51672-4069-1 Phenytoin
Product NDC 51672-4069
Requested package NDC 51672-4069-1
11-digit product format 516724069
Labeler code 51672
Product ID 51672-4069_3cbd8a0c-6cfb-e0dd-e063-6394a90a8a26
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form SUSPENSION
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
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.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
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 51672-4069-1 Phenytoin 237 mL in 1 BOTTLE SUSPENSION 237 17 51672-4069-2 Phenytoin 237 mL in 1 BOTTLE SUSPENSION 237 17 51672-4069-2 Phenytoin 1 in 1 CARTON SUSPENSION 1 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Phenytoin ACTIVE INGREDIENT 6158TKW0C5 PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 Phenytoin ACTIVE MOIETY 6158TKW0C5 PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 sucrose INACTIVE INGREDIENT C151H8M554 PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 water INACTIVE INGREDIENT 059QF0KO0R PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 Phenytoin ACTIVE INGREDIENT 6158TKW0C5 PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 5 Phenytoin ACTIVE MOIETY 6158TKW0C5 PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 5 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 5 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 5 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 5 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 5 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 5 SUCROSE INACTIVE INGREDIENT C151H8M554 PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 5 WATER INACTIVE INGREDIENT 059QF0KO0R PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4069 PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 14 Current NDC, Legacy NDC, 3 package rows 20220429_093fd736-5971-47af-b4ef-08c1696cebe8.zip
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 51672-4069-1 51672406901 237 mL in 1 BOTTLE (51672-4069-1) 237 ml 2004-04-08 2026-07-31 No No Current