Home NDC 59630-450 Furadantin
Product NDC 59630-450
11-digit product format 596300450
Labeler code 59630
Product ID 59630-450_49f55e68-c67b-40bf-a908-742c72229711
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nitrofurantoin
Dosage form SUSPENSION
Route ORAL
Labeler Shionogi Inc.
Application NDA009175
Marketing category NDA
Marketing start 1953-12-23
Marketing end 0000-00-00
Substance NITROFURANTOIN
Active strength 25 mg/5mL
Pharmacologic classes Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59630-450-08 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59630-450-08 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59630-450-08 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59630-450-08 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59630-450-08 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59630-450-08 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59630-450-08 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59630-450-08 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59630-450-08 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 59630-450-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 59630-450-08 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 59630-450-08 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 59630-450-08 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 N009175-001 FURADANTIN NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 N009175-002 FURADANTIN NITROFURANTOIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N009175-001 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 · 62 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 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 b00525d2431f…
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 · 1 matching rows.