FDA.reportPublic FDA data

Furosemide

Product NDC
21695-490
11-digit product format
216950490
Labeler code
21695
Product ID
21695-490_b116f624-85d5-472a-8209-c80eae8204a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distirbutors Corp
Application
ANDA078010
Marketing category
ANDA
Marketing start
2006-09-18
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-490-002019-09-24C16284748780-1934fe258-4cc8-48b1-e053-8cdaa90a720aFUROSEMIDE TABLETS, USP Rx only
21695-490-072019-09-24C16284748780-1934fe258-4cc8-48b1-e053-8cdaa90a720aFUROSEMIDE TABLETS, USP Rx only
21695-490-102019-09-24C16284748780-1934fe258-4cc8-48b1-e053-8cdaa90a720aFUROSEMIDE TABLETS, USP Rx only
21695-490-302019-09-24C16284748780-1934fe258-4cc8-48b1-e053-8cdaa90a720aFUROSEMIDE TABLETS, USP Rx only
21695-490-902019-09-24C16284748780-1934fe258-4cc8-48b1-e053-8cdaa90a720aFUROSEMIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-490-00Furosemide100 in 1 BOTTLETABLET1003
21695-490-07Furosemide7 in 1 BOTTLETABLET73
21695-490-10Furosemide10 in 1 BOTTLETABLET103
21695-490-30Furosemide30 in 1 BOTTLETABLET303
21695-490-90Furosemide90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-490-00EA - Each21695-49082294278-db34-4fd4-9830-bf822c25b08012012-07-24
21695-490-07EA - Each21695-4900297334c-fd86-4842-bf66-90f0d4c5d30e12012-07-24
21695-490-10EA - Each21695-490a57dc970-0cb7-4755-bc37-0dbc26e793b012012-07-24
21695-490-30EA - Each21695-490209d7f98-b43b-42e1-83f9-14189a3c71ee12012-07-24
21695-490-90EA - Each21695-49012a58927-d91d-4fa2-b621-b71e7093709512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FurosemideACTIVE INGREDIENT7LXU5N7ZO5FUROSEMIDE TABLET [REBEL DISTIRBUTORS CORP]3
FurosemideACTIVE MOIETY7LXU5N7ZO5FUROSEMIDE TABLET [REBEL DISTIRBUTORS CORP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFUROSEMIDE TABLET [REBEL DISTIRBUTORS CORP]3
magnesium stearateINACTIVE INGREDIENT70097M6I30FUROSEMIDE TABLET [REBEL DISTIRBUTORS CORP]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FUROSEMIDE TABLET [REBEL DISTIRBUTORS CORP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFUROSEMIDE TABLET [REBEL DISTIRBUTORS CORP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-490FUROSEMIDE TABLET [REBEL DISTIRBUTORS CORP]3Legacy NDC, 5 package rows20120223_d562faea-2800-4ed6-9213-88f072e21134.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310429furosemide 20 MG Oral TabletPSNd562faea-2800-4ed6-9213-88f072e211343
313988furosemide 40 MG Oral TabletPSNd562faea-2800-4ed6-9213-88f072e211343
310429furosemide 20 MG Oral TabletSCDd562faea-2800-4ed6-9213-88f072e211343
313988furosemide 40 MG Oral TabletSCDd562faea-2800-4ed6-9213-88f072e211343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-490-0021695049000100 in 1 BOTTLEHistorical
21695-490-07216950490077 in 1 BOTTLEHistorical
21695-490-102169504901010 in 1 BOTTLEHistorical
21695-490-302169504903030 in 1 BOTTLEHistorical
21695-490-902169504909090 in 1 BOTTLEHistorical