FDA.reportPublic FDA data

Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
68001-606
11-digit product format
680010606
Labeler code
68001
Product ID
68001-606_423848bb-3635-786b-e063-6294a90a9274
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA217357
Marketing category
ANDA
Marketing start
2023-10-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-606-00Nitrofurantoin (monohydrate/macrocrystals)100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-606-00EA - Each68001-6068605e9a5-dbcd-45b7-b7f0-27f94a6eb31112023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-606NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [BLUEPOINT LABORATORIES]2Current NDC, 1 package rows20240207_ea28d766-d6e6-43d2-8282-dc78a0381057.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNea28d766-d6e6-43d2-8282-dc78a03810573
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDea28d766-d6e6-43d2-8282-dc78a03810573
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN4553ccc1-0bad-4c75-aae2-1a1c87bc8db01
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN5087f071-5ef4-753e-e063-6294a90afb8d1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD4553ccc1-0bad-4c75-aae2-1a1c87bc8db01
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD5087f071-5ef4-753e-e063-6294a90afb8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-606-0068001060600100 CAPSULE in 1 BOTTLE (68001-606-00) 100 capsule2023-12-05NoNoCurrent