Home NDC 64980-593 Nitrofurantoin
Product NDC 64980-593
11-digit product format 649800593
Labeler code 64980
Product ID 64980-593_dfecf83b-2b30-4505-9044-bec3dce43a39
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrofurantoin
Dosage form SUSPENSION
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA212607
Marketing category ANDA
Marketing start 2023-05-11
Substance NITROFURANTOIN MONOHYDRATE
Active strength 25 mg/5mL
Pharmacologic classes Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
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 A212607-001 NITROFURANTOIN NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212607-001 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.
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 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212607-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-05-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Nitrofurantoin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITROFURANTOIN MONOHYDRATE 25 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination E1QI2CQQ1I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311989 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 64980-593-24 Nitrofurantoin 230 mL in 1 BOTTLE SUSPENSION 230 2 64980-593-24 Nitrofurantoin 1 in 1 CARTON SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-593 NITROFURANTOIN SUSPENSION [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, 2 package rows 20240608_11e700aa-66f9-4939-8a6b-a23240ae1a0b.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 Sample Exclude flag Status 64980-593-24 64980059324 1 BOTTLE in 1 CARTON (64980-593-24) / 230 mL in 1 BOTTLE 1 bottle 2023-05-11 No No Current