Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
16714-439
11-digit product format
167140439
Labeler code
16714
Product ID
16714-439_353af088-0bfd-4f93-8923-54a5be3b0aa9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
Northstar RxLLC
Application
ANDA077066
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active strength
75 mg/1; mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-439-01EA - Each16714-439c9b2ea9b-80a9-45fa-a51e-8fe1484c4f7b12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
NITROFURANTOIN MONOHYDRATEACTIVE INGREDIENTE1QI2CQQ1INITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ENITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-439NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]17Legacy NDC20240320_d0dbfce6-d5ea-41d8-b568-c021bc77457b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNb644426c-c8ba-4fe0-80c7-d9b2dde373953
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDb644426c-c8ba-4fe0-80c7-d9b2dde373953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-439-0116714043901100 CAPSULE in 1 BOTTLE (16714-439-01) 100 capsule2014-11-010000-00-00NoNoCurrent
16714-439-02167140439021000 CAPSULE in 1 BOTTLE (16714-439-02) 1000 capsule2014-11-010000-00-00NoNoCurrent