Home NDC 71288-203 Furosemide
Product NDC 71288-203
11-digit product format 712880203
Labeler code 71288
Product ID 71288-203_53a09c30-7295-4337-89a4-93d3748d6ea3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Furosemide
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA212803
Marketing category ANDA
Marketing start 2022-01-27
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 A212803-001 FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212803-001 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 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212803-001 FUROSEMIDE 10MG/ML INJECTABLE / INJECTION AP 2022-01-27 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 71288-203-02 Furosemide 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 6 71288-203-03 Furosemide 25 in 1 CARTON INJECTION, SOLUTION 25 6 71288-203-04 Furosemide 4 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 4 6 71288-203-05 Furosemide 25 in 1 CARTON INJECTION, SOLUTION 25 6 71288-203-10 Furosemide 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 6 71288-203-11 Furosemide 25 in 1 CARTON INJECTION, SOLUTION 25 6 71288-203-91 Furosemide 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 1 71288-203-92 Furosemide 25 in 1 CARTON INJECTION, SOLUTION 25 1 71288-203-93 Furosemide 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 1 71288-203-94 Furosemide 25 in 1 CARTON INJECTION, SOLUTION 25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-203 FUROSEMIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 6 package rows 20250426_a2e3c748-28ce-4c50-a182-721912919840.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 Units Marketing start Marketing end Sample Exclude flag Status 71288-203-02 71288020302 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 71288-203-03 71288020303 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-203-02) 2022-01-27 0000-00-00 No No Current 71288-203-04 71288020304 4 mL in 1 VIAL, SINGLE-DOSE 4 ml Historical 71288-203-05 71288020305 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-203-04) 2022-01-27 0000-00-00 No No Current 71288-203-10 71288020310 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 71288-203-11 71288020311 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-203-10) 2022-01-27 0000-00-00 No No Current 71288-203-91 71288020391 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 71288-203-92 71288020392 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-92) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-203-91) 2022-01-27 No No Current 71288-203-93 71288020393 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 71288-203-94 71288020394 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-94) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-203-93) 2022-01-27 No No Current