Home NDC 67544-568 Furosemide
Product NDC 67544-568
11-digit product format 675440568
Labeler code 67544
Product ID 67544-568_7a2b5130-7c3c-4407-94dc-085e4e3652d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Furosemide
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA070086
Marketing category ANDA
Marketing start 1991-03-13
Marketing end 0000-00-00
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 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A070086-001 FUROSEMIDE FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070086-001 AB
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 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070086-001 FUROSEMIDE 80MG TABLET / ORAL AB 1986-01-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 67544-568-60 2020-01-31 C162847 48780-1 9d75b9cf-f7cd-f424-e053-dadaa90a57ce FUROSEMIDE Tablets USP, 20 mg, 40 mg, 80 mg FUROSEMIDE Oral Solution USP, 40 mg per 5 mL and 10 mg per mL 67544-568-80 2020-01-31 C162847 48780-1 9d75b9cf-f7cd-f424-e053-dadaa90a57ce FUROSEMIDE Tablets USP, 20 mg, 40 mg, 80 mg FUROSEMIDE Oral Solution USP, 40 mg per 5 mL and 10 mg per mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67544-568-60 Furosemide 90 in 1 BOTTLE, PLASTIC TABLET 90 2 67544-568-80 Furosemide 180 in 1 BOTTLE, PLASTIC TABLET 180 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FUROSEMIDE ACTIVE INGREDIENT 7LXU5N7ZO5 FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FUROSEMIDE ACTIVE MOIETY 7LXU5N7ZO5 FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-568 FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 2 package rows 20140516_5e65f81d-f715-46a5-9a4c-fda01e7ff9c5.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Furosemide FUROSEMIDE Hikma Pharmaceuticals USA Inc. 9e493331-dddd-496e-abf8-61747fb67aba 2025-11-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 070086 application number: ANDA070086
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 67544-568-60 67544056860 90 in 1 BOTTLE, PLASTIC Historical 67544-568-80 67544056880 180 in 1 BOTTLE, PLASTIC Historical