Home NDC 17856-4070 Phenytoin
Product NDC 17856-4070
11-digit product format 178564070
Labeler code 17856
Product ID 17856-4070_36335944-2d3c-b82e-e063-6294a90a705c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form SUSPENSION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 17856-4070 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-4070 17856-4070-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 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 · 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 A040521-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2004-03-08 caaa826d4ba7…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…
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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-4070-1 Phenytoin 72 in 1 BOX, UNIT-DOSE SUSPENSION 72 5 17856-4070-2 Phenytoin 4 mL in 1 CUP, UNIT-DOSE SUSPENSION 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-4070 PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.] 4 Current NDC, Legacy NDC, 2 package rows 20240510_09daf485-3355-44cb-92af-072dd281e129.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 17856-4070-1 17856407001 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-4070-1) / 4 mL in 1 CUP, UNIT-DOSE (17856-4070-2) 2024-05-09 0000-00-00 No No Current 17856-4070-2 17856407002 4 mL in 1 CUP, UNIT-DOSE 4 ml Historical