Furosemide

Product NDC
68094-867
11-digit product format
680940867
Labeler code
68094
Product ID
68094-867_1fbbdc90-7827-439a-8502-6f7a41a7c936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose Inc.
Application
ANDA070433
Marketing category
ANDA
Marketing start
2016-01-28
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
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070433-001FUROSEMIDEFUROSEMIDE40MG/5MLSOLUTION / ORALRS1987-04-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORALRS1987-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORALRS1987-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-223f01610625f2…
2019-09-15 20:21 UTC2019-09A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE40 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197731Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3fd02fb5-98a0-4eda-a0ec-41faabe04706Available 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
68094-867-59Furosemide5 mL in 1 CUP, UNIT-DOSESOLUTION56
68094-867-62Furosemide10 in 1 TRAYSOLUTION106
68094-867-62Furosemide3 in 1 CASESOLUTION36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-867-59ML - Milliliter68094-867bbe87e27-de8a-4da0-8a0d-071d87b1a01b12016-04-04
68094-867-62ML - Milliliter68094-867449dfbcd-7178-4a6b-9033-28d8157b7bc212016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-867FUROSEMIDE SOLUTION [PRECISION DOSE INC.]6Current NDC, Legacy NDC, 3 package rows20240707_3fd02fb5-98a0-4eda-a0ec-41faabe04706.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDEAtlantic Biologicals Corps9c342198-7162-4cc5-bda1-bc4054a4292b2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070433
application number: ANDA070433
FurosemideFUROSEMIDEHikma Pharmaceuticals USA Inc.9e493331-dddd-496e-abf8-61747fb67aba2025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070433
application number: ANDA070433
FurosemideFUROSEMIDEPrecision Dose Inc.3fd02fb5-98a0-4eda-a0ec-41faabe047062024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070433
application number: ANDA070433
ndc (product): 68094-867

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197731furosemide 40 MG in 5 mL Oral SolutionPSN3fd02fb5-98a0-4eda-a0ec-41faabe047066
197731furosemide 8 MG/ML Oral SolutionSCD3fd02fb5-98a0-4eda-a0ec-41faabe047066
197731furosemide 40 MG per 5 ML Oral SolutionSY3fd02fb5-98a0-4eda-a0ec-41faabe047066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-867-59680940867595 mL in 1 CUP, UNIT-DOSE5 mlHistorical
68094-867-62680940867623 TRAY in 1 CASE (68094-867-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-867-59) 3 tray2016-01-280000-00-00NoNoCurrent