Furosemide

Product NDC
68094-756
11-digit product format
680940756
Labeler code
68094
Product ID
68094-756_2a35f26b-d831-48a5-ab87-14c61f0341bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose Inc.
Application
ANDA070434
Marketing category
ANDA
Marketing start
2012-10-23
Substance
FUROSEMIDE
Active strength
40 mg/4mL
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 1.

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
A070434-001FUROSEMIDEFUROSEMIDE10MG/MLSOLUTION / 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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-223f01610625f2…
2019-09-15 20:21 UTC2019-09A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALAARS1987-04-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070434-001FUROSEMIDE10MG/MLSOLUTION / ORALRS1987-04-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A070434-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070434-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070434-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070434-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070434-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070434-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A070434-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070434-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070434-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070434-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A070434-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070434-001AA1ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE40 mg/4mL

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
197730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a746634-379b-4847-a965-7607d2a71bedAvailable 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
68094-756-59Furosemide4 mL in 1 CUP, UNIT-DOSESOLUTION47
68094-756-62Furosemide10 in 1 TRAYSOLUTION107
68094-756-62Furosemide3 in 1 CASESOLUTION37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-756-59ML - Milliliter68094-756d793ab1d-a085-406d-8a3e-96eb1c5c482412013-02-13
68094-756-62ML - Milliliter68094-756143f66f4-13f0-4392-b8d5-7ecdb72f3e4912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FurosemideACTIVE INGREDIENT7LXU5N7ZO5FUROSEMIDE SOLUTION [PRECISION DOSE INC.]1
FurosemideACTIVE MOIETY7LXU5N7ZO5FUROSEMIDE SOLUTION [PRECISION DOSE INC.]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GFUROSEMIDE SOLUTION [PRECISION DOSE INC.]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8FUROSEMIDE SOLUTION [PRECISION DOSE INC.]1
Potassium CarbonateINACTIVE INGREDIENTBQN1B9B9HAFUROSEMIDE SOLUTION [PRECISION DOSE INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3FUROSEMIDE SOLUTION [PRECISION DOSE INC.]1
Saccharin sodium anhydrousINACTIVE INGREDIENTI4807BK602FUROSEMIDE SOLUTION [PRECISION DOSE INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RFUROSEMIDE SOLUTION [PRECISION DOSE INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RFUROSEMIDE SOLUTION [PRECISION DOSE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-756FUROSEMIDE SOLUTION [PRECISION DOSE INC.]7Current NDC, Legacy NDC, 3 package rows20220928_4a746634-379b-4847-a965-7607d2a71bed.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 Corp.54ed0dd9-2fa8-269a-e063-6294a90a607c2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070434
application number: ANDA070434
FurosemideFUROSEMIDEHikma Pharmaceuticals USA Inc.9e493331-dddd-496e-abf8-61747fb67aba2025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070434
application number: ANDA070434
FurosemideFUROSEMIDEPrecision Dose Inc.4a746634-379b-4847-a965-7607d2a71bed2022-09-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070434
application number: ANDA070434
ndc (product): 68094-756

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197730furosemide 10 MG in 1 mL Oral SolutionPSN4a746634-379b-4847-a965-7607d2a71bed7
197730furosemide 10 MG/ML Oral SolutionSCD4a746634-379b-4847-a965-7607d2a71bed7
197730furosemide 1 % Oral SolutionSY4a746634-379b-4847-a965-7607d2a71bed7
197730furosemide 10 MG per 1 ML Oral SolutionSY4a746634-379b-4847-a965-7607d2a71bed7
197730furosemide 40 MG per 4 ML Oral SolutionSY4a746634-379b-4847-a965-7607d2a71bed7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-756-59680940756594 mL in 1 CUP, UNIT-DOSE4 mlHistorical
68094-756-62680940756623 TRAY in 1 CASE (68094-756-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 4 mL in 1 CUP, UNIT-DOSE (68094-756-59) 3 tray2012-10-230000-00-00NoNoCurrent