FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
72162-1262
11-digit product format
721621262
Labeler code
72162
Product ID
72162-1262_373aced9-859b-4b9c-b3bc-8257a9014ae4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
72162-1262-0Nitrofurantoin1000 in 1 BOTTLECAPSULE1000101
72162-1262-1Nitrofurantoin100 in 1 BOTTLECAPSULE100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1262-0EA - Each72162-1262ac967345-32c6-45b5-805a-3b15f17b0d0712024-10-04
72162-1262-1EA - Each72162-1262bbb93c3e-856d-42f2-b9a5-c0d70ceec7de12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1262NITROFURANTOIN CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240829_56e07ad3-7224-4aaf-9a68-0d48d4abfec8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN56e07ad3-7224-4aaf-9a68-0d48d4abfec8101
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD56e07ad3-7224-4aaf-9a68-0d48d4abfec8101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1262-0721621262001000 CAPSULE in 1 BOTTLE (72162-1262-0) 1000 capsule2023-08-29NoNoHistorical
72162-1262-172162126201100 CAPSULE in 1 BOTTLE (72162-1262-1) 100 capsule2023-08-29NoNoHistorical