Home NDC 10122-901 ZYFLO
Product NDC 10122-901
11-digit product format 101220901
Labeler code 10122
Product ID 10122-901_d49e40c7-0635-4220-8b0a-c5068116ee17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zileuton
Dosage form TABLET
Route ORAL
Labeler Chiesi USA, Inc.
Application NDA020471
Marketing category NDA
Marketing start 1996-12-06
Marketing end 2027-11-30
Substance ZILEUTON
Active strength 600 mg/1
Pharmacologic classes 5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]
NDC exclude flag No
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020471-001 ZYFLO ZILEUTON 300MG TABLET / ORAL RLD 1996-12-09 N020471-003 ZYFLO ZILEUTON 600MG TABLET / ORAL RLD 1996-12-09
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 · 84 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 N020471-001 ZYFLO 300MG TABLET / ORAL RLD 1996-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020471-003 ZYFLO 600MG TABLET / ORAL RLD 1996-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020471-001 ZYFLO 300MG TABLET / ORAL RLD 1996-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020471-003 ZYFLO 600MG TABLET / ORAL RLD 1996-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020471-001 ZYFLO 300MG TABLET / ORAL RLD 1996-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020471-003 ZYFLO 600MG TABLET / ORAL RLD 1996-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020471-001 ZYFLO 300MG TABLET / ORAL 1996-12-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020471-003 ZYFLO 600MG TABLET / ORAL RLD, RS 1996-12-09 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base ZYFLO Active Ingredients# Ingredient, Strength table Ingredient Strength ZILEUTON 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1L22WVE2S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199904 Internal RxNorm lookup 211777 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 10122-901-12 ZYFLO 120 in 1 BOTTLE TABLET 120 33
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZILEUTON ACTIVE INGREDIENT V1L22WVE2S ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 ZILEUTON ACTIVE MOIETY V1L22WVE2S ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 TALC INACTIVE INGREDIENT 7SEV7J4R1U ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 25
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10122-901 ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] 30 Current NDC, Legacy NDC, 1 package rows 20220114_aee65202-fddb-497f-9f11-17cc727cb157.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 10122-901-12 10122090112 120 TABLET in 1 BOTTLE (10122-901-12) 120 tablet 1996-12-06 2027-11-30 No No Current