Home NDC 59651-798-01 FUROSEMIDE
Product NDC 59651-798
Requested package NDC 59651-798-01
11-digit product format 596510798
Labeler code 59651
Product ID 59651-798_a504ee4b-3995-45f2-898c-91116dd81d19
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FUROSEMIDE
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA218831
Marketing category ANDA
Marketing start 2025-07-17
Substance FUROSEMIDE
Active strength 80 mg/1
Pharmacologic classes Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218831-001 FUROSEMIDE FUROSEMIDE 20MG TABLET / ORAL AB 2025-07-17 A218831-002 FUROSEMIDE FUROSEMIDE 40MG TABLET / ORAL AB 2025-07-17 A218831-003 FUROSEMIDE FUROSEMIDE 80MG TABLET / ORAL AB 2025-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A218831-001 FUROSEMIDE 20MG TABLET / ORAL AB 2025-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218831-002 FUROSEMIDE 40MG TABLET / ORAL AB 2025-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218831-003 FUROSEMIDE 80MG TABLET / ORAL AB 2025-07-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218831-001 FUROSEMIDE 20MG TABLET / ORAL AB 2025-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218831-002 FUROSEMIDE 40MG TABLET / ORAL AB 2025-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218831-003 FUROSEMIDE 80MG TABLET / ORAL AB 2025-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218831-001 FUROSEMIDE 20MG TABLET / ORAL AB 2025-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218831-002 FUROSEMIDE 40MG TABLET / ORAL AB 2025-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218831-003 FUROSEMIDE 80MG TABLET / ORAL AB 2025-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218831-001 FUROSEMIDE 20MG TABLET / ORAL AB 2025-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218831-002 FUROSEMIDE 40MG TABLET / ORAL AB 2025-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218831-003 FUROSEMIDE 80MG TABLET / ORAL AB 2025-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218831-001 FUROSEMIDE 20MG TABLET / ORAL AB 2025-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218831-002 FUROSEMIDE 40MG TABLET / ORAL AB 2025-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218831-003 FUROSEMIDE 80MG TABLET / ORAL AB 2025-07-17 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218831-001 FUROSEMIDE 20MG TABLET / ORAL AB 2025-07-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218831-002 FUROSEMIDE 40MG TABLET / ORAL AB 2025-07-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218831-003 FUROSEMIDE 80MG TABLET / ORAL AB 2025-07-17 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 FUROSEMIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FUROSEMIDE 80 mg/1
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 197732 Internal RxNorm lookup 310429 Internal RxNorm lookup 313988 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 59651-798-01 FUROSEMIDE 100 in 1 BOTTLE TABLET 100 1 59651-798-05 FUROSEMIDE 500 in 1 BOTTLE TABLET 500 1
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 59651-798-01 59651079801 100 TABLET in 1 BOTTLE (59651-798-01) 100 tablet 2025-07-17 No No Current