FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
72789-340
11-digit product format
727890340
Labeler code
72789
Product ID
72789-340_373a52aa-03d1-3290-e063-6294a90ae504
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-03-21
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], 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 macrocrystals
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui1648759

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
72789-340-10nitrofurantoin macrocrystals10 in 1 BOTTLE, PLASTICCAPSULE107
72789-340-14nitrofurantoin macrocrystals14 in 1 BOTTLE, PLASTICCAPSULE147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-340-10EA - Each72789-340f089453e-cbce-492c-9c25-10b55272217712023-09-05
72789-340-14EA - Each72789-34054e1d4f7-a498-458b-9b7e-0b9c22f2861e12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-340NITROFURANTOIN MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]6Current NDC, 2 package rows20240522_f28d72be-56d7-467f-a3f8-9ffd57d0dffa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNf28d72be-56d7-467f-a3f8-9ffd57d0dffa7
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDf28d72be-56d7-467f-a3f8-9ffd57d0dffa7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-340-107278903401010 CAPSULE in 1 BOTTLE, PLASTIC (72789-340-10) 10 capsule2023-08-01NoNoCurrent
72789-340-147278903401414 CAPSULE in 1 BOTTLE, PLASTIC (72789-340-14) 14 capsule2023-08-11NoNoCurrent