Home NDC 51662-1719-3 FUROSEMIDE
Product NDC 51662-1719
Requested package NDC 51662-1719-3
11-digit product format 516621719
Labeler code 51662
Product ID 51662-1719_5e38ad23-ac85-e936-e063-6394a90ae351
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FUROSEMIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA217557
Marketing category ANDA
Marketing start 2024-12-13
Substance FUROSEMIDE
Active strength 10 mg/mL
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 44 .
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 A217557-001 FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217557-001 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 2026-10-15 13:18:30 2026-09 A217557-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217557-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217557-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217557-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217557-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217557-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217557-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217557-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217557-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217557-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-13 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FUROSEMIDE 10 mg/mL
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Furosemide FUROSEMIDE Camber Pharmaceuticals, Inc. f6221cce-e586-4002-bd14-6ec22eb14e2e 2025-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217557 application number: ANDA217557
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51662-1719-3 51662171903 25 POUCH in 1 BOX (51662-1719-3) / 1 VIAL, GLASS in 1 POUCH (51662-1719-2) / 4 mL in 1 VIAL, GLASS (51662-1719-1) 25 pouch 2024-12-13 No No Current