FDA.reportPublic FDA data

Furosemide

Product NDC
0054-8297
11-digit product format
000548297
Labeler code
0054
Product ID
0054-8297_bc62ddda-7639-4090-99f0-7dd4d13518f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA018823
Marketing category
NDA
Marketing start
1983-11-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Furosemide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7LXU5N7ZO5
Rxcui197730, 197731, 197732, 310429, 313988

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0054-8297-252022-08-05C16284748780-1e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4eFurosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-8297-252022-07-29C16284748780-1e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4eFurosemide Tablets, USP and Furosemide Oral Solution, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-8297-25Furosemide10 in 1 CARTONTABLET1018
0054-8297-25Furosemide10 in 1 BLISTER PACKTABLET1018
0054-8297-25Furosemide10 in 1 BOXTABLET101
0054-8297-25Furosemide100 in 1 BLISTER PACKTABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-8297-25EA - Each0054-82972aef6af9-ead1-4f4a-9a69-3054c5bd651b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FUROSEMIDEACTIVE INGREDIENT7LXU5N7ZO5FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
FUROSEMIDEACTIVE MOIETY7LXU5N7ZO5FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
POTASSIUM CARBONATEINACTIVE INGREDIENTBQN1B9B9HAFUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
SORBITOLINACTIVE INGREDIENT506T60A25RFUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
WATER O-15INACTIVE INGREDIENT63M8RYN44NFUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]7
FUROSEMIDEACTIVE INGREDIENT7LXU5N7ZO5FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
FUROSEMIDEACTIVE MOIETY7LXU5N7ZO5FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
colloidal silicon dioxideINACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
corn starchINACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
D&C Yellow No. 10INACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
FD&C Yellow No. 6INACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
lactose monohydrateINACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
microcrystalline celluloseINACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
orange flavoringINACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
pineapple-peach flavoringINACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
potassium carbonate 1 1/2 hydrateINACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
pregelatinized starchINACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
saccharin sodiumINACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
sodium starch glycolateINACTIVE INGREDIENTFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
SORBITOLINACTIVE INGREDIENT506T60A25RFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
stearic acidINACTIVE INGREDIENT4ELV7Z65APFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1
WATER, O-15INACTIVE INGREDIENT63M8RYN44NFUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-8297FUROSEMIDE TABLET FUROSEMIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 2 package rows20250511_9e493331-dddd-496e-abf8-61747fb67aba.zip
0054-8297FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC20070509_EA623E21-E9FD-4EF1-843B-82CBC05AF5BF.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197730furosemide 10 MG in 1 mL Oral SolutionPSN9e493331-dddd-496e-abf8-61747fb67aba18
310429furosemide 20 MG Oral TabletPSN9e493331-dddd-496e-abf8-61747fb67aba18
197731furosemide 40 MG in 5 mL Oral SolutionPSN9e493331-dddd-496e-abf8-61747fb67aba18
313988furosemide 40 MG Oral TabletPSN9e493331-dddd-496e-abf8-61747fb67aba18
197732furosemide 80 MG Oral TabletPSN9e493331-dddd-496e-abf8-61747fb67aba18
197730furosemide 10 MG/ML Oral SolutionSCD9e493331-dddd-496e-abf8-61747fb67aba18
310429furosemide 20 MG Oral TabletSCD9e493331-dddd-496e-abf8-61747fb67aba18
313988furosemide 40 MG Oral TabletSCD9e493331-dddd-496e-abf8-61747fb67aba18
197731furosemide 8 MG/ML Oral SolutionSCD9e493331-dddd-496e-abf8-61747fb67aba18
197732furosemide 80 MG Oral TabletSCD9e493331-dddd-496e-abf8-61747fb67aba18
197730furosemide 1 % Oral SolutionSY9e493331-dddd-496e-abf8-61747fb67aba18
197730furosemide 10 MG per 1 ML Oral SolutionSY9e493331-dddd-496e-abf8-61747fb67aba18
197730furosemide 40 MG per 4 ML Oral SolutionSY9e493331-dddd-496e-abf8-61747fb67aba18
197731furosemide 40 MG per 5 ML Oral SolutionSY9e493331-dddd-496e-abf8-61747fb67aba18
310429furosemide 20 MG Oral TabletPSN0a9a73b7-5717-40e8-9143-84c3b9d3053f14
313988furosemide 40 MG Oral TabletPSN0a9a73b7-5717-40e8-9143-84c3b9d3053f14
310429furosemide 20 MG Oral TabletSCD0a9a73b7-5717-40e8-9143-84c3b9d3053f14
313988furosemide 40 MG Oral TabletSCD0a9a73b7-5717-40e8-9143-84c3b9d3053f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-8297-250005482972510 BLISTER PACK in 1 CARTON (0054-8297-25) / 10 TABLET in 1 BLISTER PACK10 blister pack1983-11-100000-00-00NoNoCurrent