Furosemide

Product NDC
71610-636
11-digit product format
716100636
Labeler code
71610
Product ID
71610-636_e9231c86-1596-42eb-b1f8-61747c75f030
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076796
Marketing category
ANDA
Marketing start
2022-01-04
Substance
FUROSEMIDE
Active strength
80 mg/1
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

openFDA Listing Details

Product ID
71610-636_e9231c86-1596-42eb-b1f8-61747c75f030
SPL ID
e9231c86-1596-42eb-b1f8-61747c75f030
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Furosemide
Generic name
furosemide
Dosage form
TABLET
Route
ORAL
Marketing start
2022-01-04
Marketing category
ANDA
Application number
ANDA076796
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE]; Loop Diuretic [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
FUROSEMIDE80 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii7LXU5N7ZO5
Rxcui197732, 310429, 313988
Spl Set Id6f124d7d-a19d-4de6-8ea4-719a42eb520b
Manufacturer NameAphena Pharma Solutions - Tennessee, LLC

openFDA Package Details

Package NDCDescriptionMarketing startSample
71610-636-3030 TABLET in 1 BOTTLE (71610-636-30)2022-02-24No
71610-636-4545 TABLET in 1 BOTTLE (71610-636-45)2022-02-24No
71610-636-5360 TABLET in 1 BOTTLE (71610-636-53)2022-02-24No
71610-636-6090 TABLET in 1 BOTTLE (71610-636-60)2022-02-24No
71610-636-80180 TABLET in 1 BOTTLE (71610-636-80)2022-02-24No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7LXU5N7ZO5FUROSEMIDE54-31-9FUROSEMIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-636-307161006363030 TABLET in 1 BOTTLE (71610-636-30) 30 tablet2022-02-24NoNoHistorical
71610-636-457161006364545 TABLET in 1 BOTTLE (71610-636-45) 45 tablet2022-02-24NoNoHistorical
71610-636-537161006365360 TABLET in 1 BOTTLE (71610-636-53) 60 tablet2022-02-24NoNoHistorical
71610-636-607161006366090 TABLET in 1 BOTTLE (71610-636-60) 90 tablet2022-02-24NoNoHistorical
71610-636-8071610063680180 TABLET in 1 BOTTLE (71610-636-80) 180 tablet2022-02-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FUROSEMIDE TABLETS, USPAphena Pharma Solutions - Tennessee, LLC2022-03-10HUMAN PRESCRIPTION DRUG LABEL2