FDA.reportPublic FDA data

Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
68788-8571
11-digit product format
687888571
Labeler code
68788
Product ID
68788-8571_0b7122cf-b342-4353-88fc-d7484419a2d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA217357
Marketing category
ANDA
Marketing start
2024-01-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantoin (monohydrate/macrocrystals)
Listing expiration
2027-12-31

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
68788-8571-0Nitrofurantoin (monohydrate/macrocrystals)10 in 1 BOTTLECAPSULE102
68788-8571-1Nitrofurantoin (monohydrate/macrocrystals)14 in 1 BOTTLECAPSULE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8571-0EA - Each68788-8571685dc735-6771-4fe3-a93f-112d63782c8412024-05-16
68788-8571-1EA - Each68788-8571206ed795-b9a5-4da8-a0b4-1f42eb4436f012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8571NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240306_11e8f91c-5712-4267-9956-e619d081d1f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN11e8f91c-5712-4267-9956-e619d081d1f42
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD11e8f91c-5712-4267-9956-e619d081d1f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8571-06878885710010 CAPSULE in 1 BOTTLE (68788-8571-0) 10 capsule2024-01-25NoNoHistorical
68788-8571-16878885710114 CAPSULE in 1 BOTTLE (68788-8571-1) 14 capsule2024-01-25NoNoHistorical