Nitrofurantoin

Product NDC
63629-2464
11-digit product format
636292464
Labeler code
63629
Product ID
63629-2464_fc71d17e-601d-48b1-aee8-ae1cf1fcdd5a
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
63629-2464-1Nitrofurantoin100 in 1 BOTTLECAPSULE100111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2464-1EA - Each63629-2464314d3428-f497-4c5d-8e66-39090420fa3612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2464NITROFURANTOIN CAPSULE [BRYANT RANCH PREPACK]111Current NDC, Legacy NDC, 1 package rows20240806_bebbe5d6-f6ec-4191-bad3-b6e933da0688.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNbebbe5d6-f6ec-4191-bad3-b6e933da0688111
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDbebbe5d6-f6ec-4191-bad3-b6e933da0688111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2464-163629246401100 CAPSULE in 1 BOTTLE (63629-2464-1) 100 capsule2022-08-310000-00-00NoNoCurrent