Home NDC 0069-5471 CEREBYX
Product NDC 0069-5471
11-digit product format 000695471
Labeler code 0069
Product ID 0069-5471_fcfe3e97-071d-44d8-8235-bb6b67567c18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosphenytoin Sodium
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA020450
Marketing category NDA
Marketing start 2013-10-28
Substance FOSPHENYTOIN 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 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 N020450-001 CEREBYX FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020450-001 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 · 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 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020450-001 CEREBYX EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP RLD, RS 1996-08-05 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 CEREBYX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSPHENYTOIN 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 7VLR55452Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1670195 Internal RxNorm lookup 1670197 Internal RxNorm lookup 1670200 Internal RxNorm lookup 1670201 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 0069-5471-01 CEREBYX 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 29 0069-5471-02 CEREBYX 25 in 1 CARTON INJECTION, SOLUTION 25 29
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-5471 CEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 29 Current NDC, Legacy NDC, 2 package rows 20250521_de5a6711-4abb-4c3d-a18b-266b094ace11.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 · 2 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 0069-5471-01 00069547101 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 0069-5471-02 00069547102 25 VIAL, SINGLE-DOSE in 1 CARTON (0069-5471-02) / 2 mL in 1 VIAL, SINGLE-DOSE (0069-5471-01) 2013-10-28 0000-00-00 No No Current