Home NDC 0054-3298 Furosemide
Product NDC 0054-3298
11-digit product format 000543298
Labeler code 0054
Product ID 0054-3298_bc62ddda-7639-4090-99f0-7dd4d13518f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Furosemide
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA070433
Marketing category ANDA
Marketing start 1987-04-22
Substance FUROSEMIDE
Active strength 40 mg/5mL
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 42 .
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 A070433-001 FUROSEMIDE FUROSEMIDE 40MG/5ML SOLUTION / ORAL RS 1987-04-22
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL RS 1987-04-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL RS 1987-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070433-001 FUROSEMIDE 40MG/5ML SOLUTION / ORAL 1987-04-22 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Furosemide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FUROSEMIDE 40 mg/5mL
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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197730 Internal RxNorm lookup 197731 Internal RxNorm lookup 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-3298-63 Furosemide 500 mL in 1 BOTTLE, PLASTIC SOLUTION 500 18 0054-3298-63 Furosemide 500 mL in 1 BOTTLE, PLASTIC SOLUTION 500 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FUROSEMIDE ACTIVE INGREDIENT 7LXU5N7ZO5 FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 FUROSEMIDE ACTIVE MOIETY 7LXU5N7ZO5 FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 POTASSIUM CARBONATE INACTIVE INGREDIENT BQN1B9B9HA FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 SACCHARIN SODIUM ANHYDROUS INACTIVE INGREDIENT I4807BK602 FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 SORBITOL INACTIVE INGREDIENT 506T60A25R FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 WATER O-15 INACTIVE INGREDIENT 63M8RYN44N FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC] 7 FUROSEMIDE ACTIVE INGREDIENT 7LXU5N7ZO5 FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 FUROSEMIDE ACTIVE MOIETY 7LXU5N7ZO5 FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 colloidal silicon dioxide INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 corn starch INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 D&C Yellow No. 10 INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 FD&C Yellow No. 6 INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 lactose monohydrate INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 microcrystalline cellulose INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 orange flavoring INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 pineapple-peach flavoring INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 potassium carbonate 1 1/2 hydrate INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 pregelatinized starch INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 saccharin sodium INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 sodium starch glycolate INACTIVE INGREDIENT FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 SORBITOL INACTIVE INGREDIENT 506T60A25R FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1 WATER, O-15 INACTIVE INGREDIENT 63M8RYN44N FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3298 FUROSEMIDE TABLET FUROSEMIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 16 Current NDC, Legacy NDC, 1 package rows 20250511_9e493331-dddd-496e-abf8-61747fb67aba.zip 0054-3298 FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC 20070509_EA623E21-E9FD-4EF1-843B-82CBC05AF5BF.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 · 3 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 0054-3298-63 00054329863 500 mL in 1 BOTTLE, PLASTIC (0054-3298-63) 500 ml 1987-04-22 0000-00-00 No No Current