Home NDC 42571-393 Nitrofurantoin
Product NDC 42571-393
11-digit product format 425710393
Labeler code 42571
Product ID 42571-393_35155f61-5d28-d364-e063-6294a90aa4c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrofurantoin
Dosage form CAPSULE
Route ORAL
Labeler Micro Labs Limited
Application ANDA217073
Marketing category ANDA
Marketing start 2024-04-01
Substance NITROFURANTOIN
Active strength 100 mg/1
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 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG CAPSULE / ORAL AB 2023-11-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217073-001 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 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217073-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2023-11-03 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 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 927AH8112L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1648755 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 42571-393-01 Nitrofurantoin 100 in 1 BOTTLE CAPSULE 100 2 42571-393-05 Nitrofurantoin 500 in 1 BOTTLE CAPSULE 500 2 42571-393-90 Nitrofurantoin 90 in 1 BOTTLE CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-393 NITROFURANTOIN CAPSULE [MICRO LABS LIMITED] 2 Current NDC, 3 package rows 20250515_d96098d0-3c2b-4e53-a3f0-3ebba81c4133.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 Sample Exclude flag Status 42571-393-01 42571039301 100 CAPSULE in 1 BOTTLE (42571-393-01) 100 capsule 2024-04-01 No No Current 42571-393-05 42571039305 500 CAPSULE in 1 BOTTLE (42571-393-05) 500 capsule 2024-04-01 No No Current 42571-393-90 42571039390 90 CAPSULE in 1 BOTTLE (42571-393-90) 90 capsule 2024-04-01 No No Current