Home NDC 0071-2214-35 Dilantin-125
Product NDC 0071-2214
Requested package NDC 0071-2214-35
11-digit product format 000712214
Labeler code 0071
Product ID 0071-2214_2290658d-13e5-43f6-805f-614c8baa613c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form SUSPENSION
Route ORAL
Labeler Parke-Davis Div of Pfizer Inc
Application NDA008762
Marketing category NDA
Marketing start 1953-01-06
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0071-2214 0071-2214-35 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0071-2214 0071-2214-35 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N008762-001 DILANTIN-125 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 N008762-002 DILANTIN-30 PHENYTOIN 30MG/5ML SUSPENSION / ORAL Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N008762-001 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 3 · 82 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 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N008762-001 DILANTIN-125 125MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N008762-002 DILANTIN-30 30MG/5ML SUSPENSION / ORAL Approved before 1982 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# 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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0071-2214-35 00071221435 1 BOTTLE, PLASTIC in 1 CARTON (0071-2214-35) > 237 mL in 1 BOTTLE, PLASTIC 2020-10-12 0000-00-00 No No Current