Home NDC 42192-614 PHENYTOIN SODIUM
Product NDC 42192-614
11-digit product format 421920614
Labeler code 42192
Product ID 42192-614_ae14cce7-f65a-45e0-8ff4-9388d0a806d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHENYTOIN SODIUM
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Acella Pharmaceuticals, LLC
Application ANDA040573
Marketing category ANDA
Marketing start 2021-12-01
Substance PHENYTOIN SODIUM
Active strength 50 mg/mL
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 A040573-001 PHENYTOIN SODIUM PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040573-001 AP
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 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 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 SODIUM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYTOIN SODIUM 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4182431BJH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1670351 Internal RxNorm lookup 1670353 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 42192-614-10 PHENYTOIN SODIUM 10 in 1 CARTON INJECTION 10 7 42192-614-10 PHENYTOIN SODIUM 2 mL in 1 VIAL INJECTION 2 7 42192-614-30 PHENYTOIN SODIUM 10 in 1 CARTON INJECTION 10 7 42192-614-30 PHENYTOIN SODIUM 5 mL in 1 VIAL INJECTION 5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42192-614 PHENYTOIN SODIUM INJECTION [ACELLA PHARMACEUTICALS, LLC] 7 Current NDC, Legacy NDC, 4 package rows 20240918_6922f32f-8bed-4c09-8103-27987bcbd104.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 42192-614-03 42192061403 25 VIAL in 1 CARTON (42192-614-03) > 2 mL in 1 VIAL 25 vial 2021-12-30 0000-00-00 No No Current 42192-614-06 42192061406 25 VIAL in 1 CARTON (42192-614-06) > 5 mL in 1 VIAL 25 vial 2021-12-30 0000-00-00 No No Current 42192-614-10 42192061410 10 VIAL in 1 CARTON (42192-614-10) / 2 mL in 1 VIAL 10 vial 2021-12-30 0000-00-00 No No Current 42192-614-30 42192061430 10 VIAL in 1 CARTON (42192-614-30) / 5 mL in 1 VIAL 10 vial 2021-12-30 0000-00-00 No No Current