Home NDC 0378-0208 Furosemide
Product NDC 0378-0208
11-digit product format 003780208
Labeler code 0378
Product ID 0378-0208_0d7d06e2-2804-4a02-b9d6-2f70d9d45c4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name furosemide
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA018487
Marketing category NDA
Marketing start 1981-08-27
Marketing end 0000-00-00
Substance FUROSEMIDE
Active strength 20 mg/1
Pharmacologic classes Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 34 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018487-001 FUROSEMIDE FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 N018487-002 FUROSEMIDE FUROSEMIDE 40MG TABLET / ORAL Approved before 1982
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 3 · 84 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 N018487-001 FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018487-002 FUROSEMIDE 40MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018487-001 FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018487-002 FUROSEMIDE 40MG TABLET / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018487-001 FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018487-002 FUROSEMIDE 40MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018487-001 FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018487-002 FUROSEMIDE 40MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018487-001 FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018487-002 FUROSEMIDE 40MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018487-001 FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018487-002 FUROSEMIDE 40MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018487-001 FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018487-002 FUROSEMIDE 40MG TABLET / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018487-001 FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018487-002 FUROSEMIDE 40MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018487-001 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018487-002 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018487-001 FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018487-002 FUROSEMIDE 40MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018487-001 FUROSEMIDE 20MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018487-002 FUROSEMIDE 40MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018487-001 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018487-002 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018487-001 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018487-002 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018487-001 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018487-002 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018487-001 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018487-002 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018487-001 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018487-002 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018487-001 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018487-002 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018487-001 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018487-002 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018487-001 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018487-002 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018487-001 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018487-002 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FUROSEMIDE ACTIVE INGREDIENT 7LXU5N7ZO5 FUROSEMIDE TABLET [BRYANT RANCH PREPACK] 1001 FUROSEMIDE ACTIVE MOIETY 7LXU5N7ZO5 FUROSEMIDE TABLET [BRYANT RANCH PREPACK] 1001 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FUROSEMIDE TABLET [BRYANT RANCH PREPACK] 1001 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FUROSEMIDE TABLET [BRYANT RANCH PREPACK] 1001 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FUROSEMIDE TABLET [BRYANT RANCH PREPACK] 1001 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FUROSEMIDE TABLET [BRYANT RANCH PREPACK] 1001 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FUROSEMIDE TABLET [BRYANT RANCH PREPACK] 1001 Furosemide ACTIVE INGREDIENT 7LXU5N7ZO5 FUROSEMIDE TABLET [MYLAN PHARMACEUTICALS INC.] 10 Furosemide ACTIVE MOIETY 7LXU5N7ZO5 FUROSEMIDE TABLET [MYLAN PHARMACEUTICALS INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FUROSEMIDE TABLET [MYLAN PHARMACEUTICALS INC.] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FUROSEMIDE TABLET [MYLAN PHARMACEUTICALS INC.] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FUROSEMIDE TABLET [MYLAN PHARMACEUTICALS INC.] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FUROSEMIDE TABLET [MYLAN PHARMACEUTICALS INC.] 10 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FUROSEMIDE TABLET [MYLAN PHARMACEUTICALS INC.] 10 FUROSEMIDE ACTIVE INGREDIENT 7LXU5N7ZO5 FUROSEMIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 FUROSEMIDE ACTIVE MOIETY 7LXU5N7ZO5 FUROSEMIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FUROSEMIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FUROSEMIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FUROSEMIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FUROSEMIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FUROSEMIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 FUROSEMIDE ACTIVE INGREDIENT 7LXU5N7ZO5 FUROSEMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FUROSEMIDE ACTIVE MOIETY 7LXU5N7ZO5 FUROSEMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FUROSEMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FUROSEMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FUROSEMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FUROSEMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FUROSEMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
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 0378-0208-01 00378020801 100 TABLET in 1 BOTTLE, PLASTIC (0378-0208-01) 100 tablet 1981-08-27 0000-00-00 No No Current 0378-0208-10 00378020810 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0208-10) 1000 tablet 1981-08-27 0000-00-00 No No Current