FDA.reportPublic FDA data

Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
72789-242
11-digit product format
727890242
Labeler code
72789
Product ID
72789-242_47a942d9-4842-7a93-e063-6394a90abf65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077066
Marketing category
ANDA
Marketing start
2005-04-06
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-242-02Nitrofurantoin (monohydrate/macrocrystals)2 in 1 BOTTLE, PLASTICCAPSULE229
72789-242-06Nitrofurantoin (monohydrate/macrocrystals)6 in 1 BOTTLE, PLASTICCAPSULE629
72789-242-10Nitrofurantoin (monohydrate/macrocrystals)10 in 1 BOTTLE, PLASTICCAPSULE1029
72789-242-14Nitrofurantoin (monohydrate/macrocrystals)14 in 1 BOTTLE, PLASTICCAPSULE1429

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-242-02EA - Each72789-242acb81fd2-30db-48fd-bc69-99546b000eba12023-07-06
72789-242-06EA - Each72789-2420ba52a15-e145-46da-b793-1344c0326bff12023-02-06
72789-242-10EA - Each72789-242d8276f9d-96dd-483c-b5c1-0eedd3ef2af712022-05-04
72789-242-14EA - Each72789-242a03df368-d9a3-430c-8d18-c9390106876912022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-242NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [PD-RX PHARMACEUTICALS, INC.]27Current NDC, Legacy NDC, 4 package rows20240906_643cdcff-8599-4326-b3ca-d9fd270e0fc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN643cdcff-8599-4326-b3ca-d9fd270e0fc229
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD643cdcff-8599-4326-b3ca-d9fd270e0fc229

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-242-02727890242022 CAPSULE in 1 BOTTLE, PLASTIC (72789-242-02) 2 capsule2023-06-13NoNoHistorical
72789-242-06727890242066 CAPSULE in 1 BOTTLE, PLASTIC (72789-242-06) 6 capsule2022-09-290000-00-00NoNoCurrent
72789-242-107278902421010 CAPSULE in 1 BOTTLE, PLASTIC (72789-242-10) 10 capsule2022-04-140000-00-00NoNoCurrent
72789-242-147278902421414 CAPSULE in 1 BOTTLE, PLASTIC (72789-242-14) 14 capsule2022-04-080000-00-00NoNoCurrent