Home NDC 70069-829 Nitrofurantoin
Product NDC 70069-829
11-digit product format 700690829
Labeler code 70069
Product ID 70069-829_40efa147-f323-4d77-9a88-227434ff84c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrofurantoin
Dosage form FOR SUSPENSION
Route ORAL
Labeler Somerset Therapeutics, LLC
Application ANDA208909
Marketing category ANDA
Marketing start 2025-02-26
Substance NITROFURANTOIN
Active strength 25 mg/5mL
Pharmacologic classes Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A208909-001 NITROFURANTOIN NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2025-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208909-001 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 A208909-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2025-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208909-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2025-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208909-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2025-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208909-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2025-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208909-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2025-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208909-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2025-01-14 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208909-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2025-01-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Nitrofurantoin
Listing expiration 2027-12-31 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 70069-829-01 Nitrofurantoin 230 mL in 1 BOTTLE, GLASS FOR SUSPENSION 230 3 70069-829-01 Nitrofurantoin 1 in 1 CARTON FOR SUSPENSION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-829 NITROFURANTOIN FOR SUSPENSION [SOMERSET THERAPEUTICS, LLC] 1 Current NDC, 2 package rows 20250227_dd99ba40-edff-47c3-9ee4-7e5b7774e5b5.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 Marketing start Sample Exclude flag Status 70069-829-01 70069082901 1 BOTTLE, GLASS in 1 CARTON (70069-829-01) / 230 mL in 1 BOTTLE, GLASS 2025-02-26 No No Current