Furosemide

Product NDC
62135-753
Requested package NDC
62135-753-90
11-digit product format
621350753
Labeler code
62135
Product ID
62135-753_31443d9b-3dee-5aa9-e063-6294a90adcfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
NDA018413
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1983-11-30
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018413-001FUROSEMIDEFUROSEMIDE20MGTABLET / ORAL1983-11-30
N018413-002FUROSEMIDEFUROSEMIDE40MGTABLET / ORAL1983-11-30

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-3084e616aacf4f…
2026-09-14 22:38:342026-08N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-3084e616aacf4f…
2026-08-18 06:07:402026-07N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018413-001FUROSEMIDE20MGTABLET / ORAL1983-11-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018413-002FUROSEMIDE40MGTABLET / ORAL1983-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018413-001FUROSEMIDE20MGTABLET / ORALAB1983-11-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018413-002FUROSEMIDE40MGTABLET / ORALAB1983-11-3074a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N018413-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018413-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N018413-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N018413-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018413-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N018413-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018413-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N018413-002AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Furosemide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7LXU5N7ZO5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310429Internal RxNorm lookup
313988Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ebd2f10-acfc-48a4-a5db-f20377bda9ceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d80d3aff-3a63-4d7b-a2be-fd9388b04330Product name920250806
9061e89f-9c86-4196-b34b-886fc1673cc4Product name120140821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-753-90Furosemide90 in 1 PACKAGETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-753-90EA - Each62135-75357bbba1e-59fe-4c7f-808f-2766f0b2c8c012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-753FUROSEMIDE TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20250328_8ebd2f10-acfc-48a4-a5db-f20377bda9ce.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDEChartwell RX, LLC8ebd2f10-acfc-48a4-a5db-f20377bda9ce2025-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 018413
application number: NDA018413
ndc (package): 62135-753-90
ndc (product): 62135-753
ndc11 (package): 62135075390

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310429furosemide 20 MG Oral TabletPSN8ebd2f10-acfc-48a4-a5db-f20377bda9ce2
313988furosemide 40 MG Oral TabletPSN8ebd2f10-acfc-48a4-a5db-f20377bda9ce2
310429furosemide 20 MG Oral TabletSCD8ebd2f10-acfc-48a4-a5db-f20377bda9ce2
313988furosemide 40 MG Oral TabletSCD8ebd2f10-acfc-48a4-a5db-f20377bda9ce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-753-906213507539090 TABLET in 1 PACKAGE (62135-753-90) 90 tablet2024-04-17NoNoCurrent