FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
72789-386
11-digit product format
727890386
Labeler code
72789
Product ID
72789-386_40c03d65-8d08-371a-e063-6294a90a7ac6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA208516
Marketing category
ANDA
Marketing start
2018-01-01
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-386-06Nitrofurantoin6 in 1 BOTTLE, PLASTICCAPSULE69
72789-386-10Nitrofurantoin10 in 1 BOTTLE, PLASTICCAPSULE109
72789-386-14Nitrofurantoin14 in 1 BOTTLE, PLASTICCAPSULE149

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-386-06EA - Each72789-386febf3495-e9c2-47e7-ad8a-9ef35fc365e812024-05-16
72789-386-10EA - Each72789-386293a751f-19e0-437c-a3af-06e9ad4f0b5f12024-04-05
72789-386-14EA - Each72789-3868f20091c-f6ed-49a9-902a-f6678555980312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-386NITROFURANTOIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]8Current NDC, 3 package rows20240405_37606c6f-0d85-4314-94ae-f7732c7bc8d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN37606c6f-0d85-4314-94ae-f7732c7bc8d59
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD37606c6f-0d85-4314-94ae-f7732c7bc8d59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-386-06727890386066 CAPSULE in 1 BOTTLE, PLASTIC (72789-386-06) 6 capsule2024-04-03NoNoCurrent
72789-386-107278903861010 CAPSULE in 1 BOTTLE, PLASTIC (72789-386-10) 10 capsule2024-02-27NoNoCurrent
72789-386-147278903861414 CAPSULE in 1 BOTTLE, PLASTIC (72789-386-14) 14 capsule2024-02-27NoNoCurrent