Home NDC 68083-433 Furosemide
Product NDC 68083-433
11-digit product format 680830433
Labeler code 68083
Product ID 68083-433_e7bd6ac5-0b85-49a8-b4a3-131d95b1764a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Furosemide
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA213902
Marketing category ANDA
Marketing start 2020-07-01
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 2026-12-31
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 A213902-001 FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213902-001 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 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213902-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2020-07-01 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Furosemide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FUROSEMIDE 10 mg/mL
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 68083-433-05 Furosemide 4 mL in 1 VIAL, GLASS INJECTION, SOLUTION 4 3 68083-433-05 Furosemide 5 in 1 BOX INJECTION, SOLUTION 5 3 68083-433-25 Furosemide 25 in 1 BOX INJECTION, SOLUTION 25 3 68083-433-25 Furosemide 4 mL in 1 VIAL, GLASS INJECTION, SOLUTION 4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-433 FUROSEMIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] 3 Current NDC, Legacy NDC, 4 package rows 20200703_644704c0-e6a5-4804-bfa6-795c8f83aa7a.zip
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 Marketing start Marketing end Sample Exclude flag Status 68083-433-05 68083043305 5 VIAL, GLASS in 1 BOX (68083-433-05) / 4 mL in 1 VIAL, GLASS 2020-07-01 0000-00-00 No No Current 68083-433-25 68083043325 25 VIAL, GLASS in 1 BOX (68083-433-25) / 4 mL in 1 VIAL, GLASS 2020-07-01 0000-00-00 No No Current