Home NDC 70199-006 Furadantin
Product NDC 70199-006
11-digit product format 701990006
Labeler code 70199
Product ID 70199-006_53b84bd6-6672-4376-8207-84fa5d553e0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrofurantoin
Dosage form SUSPENSION
Route ORAL
Labeler Casper Pharma LLC
Application NDA009175
Marketing category NDA
Marketing start 2020-12-23
Marketing end 0000-00-00
Substance NITROFURANTOIN
Active strength 25 mg/5mL
Pharmacologic classes Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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.
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 2026-08-01 22:54:32 2026-06 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N009175-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70199-006 FURADANTIN (NITROFURANTOIN) SUSPENSION [CASPER PHARMA LLC] 14 Legacy NDC 20240405_00af0dea-ac7b-43f2-9f51-2a9f9e7f7d21.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70199-006-32 70199000632 1 BOTTLE in 1 CARTON (70199-006-32) > 230 mL in 1 BOTTLE 1 bottle 2020-12-23 0000-00-00 No No Current