Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC
33261-160
11-digit product format
332610160
Labeler code
33261
Product ID
33261-160_287b7aba-b3e7-4a98-ac8b-474f17157b0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-160-06Nitrofurantoin Monohydrate/ Macrocrystalline6 in 1 BOTTLE, PLASTICCAPSULE62
33261-160-10Nitrofurantoin Monohydrate/ Macrocrystalline10 in 1 BOTTLE, PLASTICCAPSULE102
33261-160-14Nitrofurantoin Monohydrate/ Macrocrystalline14 in 1 BOTTLE, PLASTICCAPSULE142
33261-160-20Nitrofurantoin Monohydrate/ Macrocrystalline20 in 1 BOTTLE, PLASTICCAPSULE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-160-10EA - Each33261-1602de3f4c1-c7cf-4e4a-9e1f-3174acc6d0a312015-10-02
33261-160-14EA - Each33261-1601328f541-ed41-4e35-9ea6-ae71580d00fe12015-10-02
33261-160-20EA - Each33261-1608b809564-f414-4ba0-9123-d867b0ce427412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
NITROFURANTOIN MONOHYDRATEACTIVE INGREDIENTE1QI2CQQ1INITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-160NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 4 package rows20140128_9a28e7c3-f25e-4341-9cda-f143be125e69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN9a28e7c3-f25e-4341-9cda-f143be125e692
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD9a28e7c3-f25e-4341-9cda-f143be125e692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-160-06332610160066 in 1 BOTTLE, PLASTICHistorical
33261-160-103326101601010 in 1 BOTTLE, PLASTICHistorical
33261-160-143326101601414 in 1 BOTTLE, PLASTICHistorical
33261-160-203326101602020 in 1 BOTTLE, PLASTICHistorical