Home NDC 72603-176 Nitrofurantoin
Product NDC 72603-176
11-digit product format 726030176
Labeler code 72603
Product ID 72603-176_14c9efac-c0b1-7afe-e063-6294a90a39e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrofurantoin
Dosage form SUSPENSION
Route ORAL
Labeler NorthStar Rx LLC
Application ANDA216385
Marketing category ANDA
Marketing start 2023-04-17
Substance NITROFURANTOIN
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 43 .
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 A216385-001 NITROFURANTOIN NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216385-001 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 2026-09-14 22:38:34 2026-08 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216385-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2023-04-14 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nitrofurantoin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITROFURANTOIN 25 mg/5mL
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 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 72603-176-01 Nitrofurantoin 230 mL in 1 BOTTLE SUSPENSION 230 2 72603-176-01 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 72603-176 NITROFURANTOIN SUSPENSION [NORTHSTAR RX LLC] 2 Current NDC, 2 package rows 20240420_04af8b73-7e15-7da8-e063-6294a90af284.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 72603-176-01 72603017601 1 BOTTLE in 1 CARTON (72603-176-01) / 230 mL in 1 BOTTLE 1 bottle 2023-04-17 No No Current