FDA.reportPublic FDA data

Furosemide

Product NDC
33261-374
11-digit product format
332610374
Labeler code
33261
Product ID
33261-374_8e5a1b85-9468-4dc3-94b8-06cda657d5b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078010
Marketing category
ANDA
Marketing start
2009-01-29
Marketing end
0000-00-00
Substance
FUROSEMIDE
Active strength
40 mg/1
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-374-002020-01-31C16284748780-19d75b9d0-1db9-f424-e053-dadaa90a57ceFurosemide Tablets, USP Rx Only
33261-374-302020-01-31C16284748780-19d75b9d0-1db9-f424-e053-dadaa90a57ceFurosemide Tablets, USP Rx Only
33261-374-602020-01-31C16284748780-19d75b9d0-1db9-f424-e053-dadaa90a57ceFurosemide Tablets, USP Rx Only
33261-374-902020-01-31C16284748780-19d75b9d0-1db9-f424-e053-dadaa90a57ceFurosemide Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-374-00Furosemide100 in 1 BOTTLE, PLASTICTABLET1001
33261-374-30Furosemide30 in 1 BOTTLE, PLASTICTABLET301
33261-374-60Furosemide60 in 1 BOTTLE, PLASTICTABLET601
33261-374-90Furosemide90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-374-30EA - Each33261-3746204bfa1-fdfb-415d-bb48-7f0bdada769412015-10-02
33261-374-60EA - Each33261-37459b1b577-e347-40cd-ac06-85b86636f97f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FUROSEMIDEACTIVE INGREDIENT7LXU5N7ZO5FUROSEMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FUROSEMIDEACTIVE MOIETY7LXU5N7ZO5FUROSEMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFUROSEMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FUROSEMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FUROSEMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFUROSEMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RFUROSEMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-374FUROSEMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140110_22da65c8-759c-4b06-921b-feef9bf06178.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310429furosemide 20 MG Oral TabletPSN22da65c8-759c-4b06-921b-feef9bf061781
313988furosemide 40 MG Oral TabletPSN22da65c8-759c-4b06-921b-feef9bf061781
310429furosemide 20 MG Oral TabletSCD22da65c8-759c-4b06-921b-feef9bf061781
313988furosemide 40 MG Oral TabletSCD22da65c8-759c-4b06-921b-feef9bf061781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-374-0033261037400100 in 1 BOTTLE, PLASTICHistorical
33261-374-303326103743030 in 1 BOTTLE, PLASTICHistorical
33261-374-603326103746060 in 1 BOTTLE, PLASTICHistorical
33261-374-903326103749090 in 1 BOTTLE, PLASTICHistorical