Home NDC 63561-0166 Furosemide
Product NDC 63561-0166
11-digit product format 635610166
Labeler code 63561
Product ID 63561-0166_4870846b-dfe5-84bd-e063-6294a90aa56f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FUROSEMIDE
Dosage form TABLET
Route ORAL
Labeler Granulation Technology, Inc.
Application NDA018569
Marketing category NDA
Marketing start 2025-12-18
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 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018569-001 FUROSEMIDE FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 N018569-002 FUROSEMIDE FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 N018569-005 FUROSEMIDE FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14
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.
Product history page 1 of 4 · 123 observed 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 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Furosemide
Listing expiration 2027-12-31 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 63561-0166-1 Furosemide 100 in 1 BOTTLE TABLET 100 2 63561-0166-5 Furosemide 500 in 1 BOTTLE TABLET 500 2 63561-0166-9 Furosemide 90 in 1 BOTTLE TABLET 90 2
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 63561-0166-1 63561016601 100 TABLET in 1 BOTTLE (63561-0166-1) 100 tablet 2026-01-15 No No Current 63561-0166-5 63561016605 500 TABLET in 1 BOTTLE (63561-0166-5) 500 tablet 2025-12-18 No No Current 63561-0166-9 63561016609 90 TABLET in 1 BOTTLE (63561-0166-9) 90 tablet 2025-12-18 No No Current