Home NDC 42571-436 Furosemide
Product NDC 42571-436
11-digit product format 425710436
Labeler code 42571
Product ID 42571-436_4829e889-87d2-9d87-e063-6294a90a11cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Furosemide
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Micro Labs Limited
Application ANDA218188
Marketing category ANDA
Marketing start 2023-11-16
Substance FUROSEMIDE
Active strength 20 mg/2mL
Pharmacologic classes Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
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 1 .
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 A218188-001 FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2026-01-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218188-001 AP
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 2026-02-19 14:30 UTC 2026-02 A218188-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2026-01-08 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218188-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2026-01-08 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218188-001 AP 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218188-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Furosemide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FUROSEMIDE 20 mg/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7LXU5N7ZO5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1719286 Internal RxNorm lookup 1719290 Internal RxNorm lookup 1719291 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 42571-436-75 Furosemide 2 mL in 1 VIAL INJECTION 2 3 42571-436-87 Furosemide 25 in 1 CARTON INJECTION 25 3
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 42571-436-75 42571043675 2 mL in 1 VIAL 2 ml Historical 42571-436-87 42571043687 25 VIAL in 1 CARTON (42571-436-87) / 2 mL in 1 VIAL (42571-436-75) 25 vial 2023-11-16 No No Current