Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC
42254-064
11-digit product format
422540064
Labeler code
42254
Product ID
42254-064_e5b36fbf-4db1-43b3-bf04-39022f74d0b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020064
Marketing category
NDA
Marketing start
2011-05-25
Marketing end
0000-00-00
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-064-142019-09-24C16284748780-19350213a-3c7a-c013-e053-90daa90a1393Nitrofurantoin Monohydrate/Macrocrystals Capsule

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-064-14Nitrofurantoin Monohydrate/ Macrocrystalline14 in 1 BOTTLECAPSULE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-064-14EA - Each42254-0648d0b21a9-6da3-4da9-863c-fd9d8fa0262112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
NITROFURANTOIN MONOHYDRATEACTIVE INGREDIENTE1QI2CQQ1INITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-064NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120411_e5b36fbf-4db1-43b3-bf04-39022f74d0b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNe5b36fbf-4db1-43b3-bf04-39022f74d0b91
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDe5b36fbf-4db1-43b3-bf04-39022f74d0b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-064-144225400641414 in 1 BOTTLEHistorical