FDA.reportPublic FDA data

Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC
10544-086
11-digit product format
105440086
Labeler code
10544
Product ID
10544-086_1168f072-08bf-485c-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
NDA020064
Marketing category
NDA
Marketing start
2012-09-06
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-086-142020-01-31C16284748780-19d75b9d0-f88f-f424-e053-dadaa90a57ceNitrofurantoin Monohydrate/Macrocrystals Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-086-14Nitrofurantoin Monohydrate/ Macrocrystalline14 in 1 BOTTLECAPSULE141

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-086NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150316_1168f072-08be-485c-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN1168f072-08be-485c-e054-00144ff8d46c1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD1168f072-08be-485c-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-086-141054400861414 in 1 BOTTLEHistorical