Home NDC 71610-305-80 Furosemide
Product NDC 71610-305
Requested package NDC 71610-305-80
11-digit product format 716100305
Labeler code 71610
Product ID 71610-305_f0960a17-009b-4da4-b2cc-7851e22a2165
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 1986-01-24
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 2020-12-31
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 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-305-60 Furosemide 90 in 1 BOTTLE, PLASTIC TABLET 90 1 71610-305-80 Furosemide 180 in 1 BOTTLE, PLASTIC TABLET 180 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-305 FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 2 package rows 20190817_a0dd45a3-4ae8-4301-8d6c-a20eac80cb2c.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 Units Marketing start Marketing end Sample Exclude flag Status 71610-305-80 71610030580 180 TABLET in 1 BOTTLE, PLASTIC (71610-305-80) 180 tablet 2019-07-16 0000-00-00 No No Current