FDA.reportPublic FDA data

Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
76420-195
11-digit product format
764200195
Labeler code
76420
Product ID
76420-195_e9294cf2-886b-1f04-e053-2995a90a3984
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA077066
Marketing category
ANDA
Marketing start
2005-04-06
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25; 75 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantoin (monohydrate/macrocrystals)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN25 mg/1
NITROFURANTOIN MONOHYDRATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L, E1QI2CQQ1I
Rxcui1648755

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d02ec8bb-3b28-9b95-8719-8dbb1a2ec5cfProduct name620251106
f6207266-e92b-4b5b-a91b-4af4215c9542Product name620240813
e31776f7-6119-9577-e170-5b569993276eProduct name520240320
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-195-01Nitrofurantoin (monohydrate/macrocrystals)100 in 1 BOTTLECAPSULE1002
76420-195-10Nitrofurantoin (monohydrate/macrocrystals)10 in 1 BOTTLECAPSULE102
76420-195-14Nitrofurantoin (monohydrate/macrocrystals)14 in 1 BOTTLECAPSULE142
76420-195-20Nitrofurantoin (monohydrate/macrocrystals)20 in 1 BOTTLECAPSULE202
76420-195-30Nitrofurantoin (monohydrate/macrocrystals)30 in 1 BOTTLECAPSULE302
76420-195-60Nitrofurantoin (monohydrate/macrocrystals)60 in 1 BOTTLECAPSULE602
76420-195-90Nitrofurantoin (monohydrate/macrocrystals)90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-195-10EA - Each76420-1953c3b41be-2d65-4b73-80be-e445390e8aea12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-195NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 7 package rows20220922_1ab658f0-021a-46a1-bff3-d3334c23442d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN1ab658f0-021a-46a1-bff3-d3334c23442d2
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD1ab658f0-021a-46a1-bff3-d3334c23442d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-195-0176420019501100 CAPSULE in 1 BOTTLE (76420-195-01) 100 capsule2022-09-210000-00-00NoNoCurrent
76420-195-107642001951010 CAPSULE in 1 BOTTLE (76420-195-10) 10 capsule2021-11-300000-00-00NoNoCurrent
76420-195-147642001951414 CAPSULE in 1 BOTTLE (76420-195-14) 14 capsule2022-09-210000-00-00NoNoCurrent
76420-195-207642001952020 CAPSULE in 1 BOTTLE (76420-195-20) 20 capsule2022-09-210000-00-00NoNoCurrent
76420-195-307642001953030 CAPSULE in 1 BOTTLE (76420-195-30) 30 capsule2022-09-210000-00-00NoNoCurrent
76420-195-607642001956060 CAPSULE in 1 BOTTLE (76420-195-60) 60 capsule2022-09-210000-00-00NoNoCurrent
76420-195-907642001959090 CAPSULE in 1 BOTTLE (76420-195-90) 90 capsule2022-09-210000-00-00NoNoCurrent