FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
47781-307
11-digit product format
477810307
Labeler code
47781
Product ID
47781-307_97785cf3-ab56-4697-3ab6-7451919d889a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Alvogen Inc.
Application
NDA016620
Marketing category
NDA
Marketing start
2010-09-27
Substance
NITROFURANTOIN
Active strength
50 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nitrofurantoin macrocrystals
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui311994, 311995, 1648759

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
47781-307-01nitrofurantoin macrocrystals100 in 1 BOTTLE, PLASTICCAPSULE10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-307-01EA - Each47781-30787f349cb-17c4-446a-8c7a-59f8a23aa29d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-307NITROFURANTOIN MACROCRYSTALS CAPSULE [ALVOGEN INC. ]18Current NDC, Legacy NDC, 1 package rows20241018_62c1bb9c-79a2-41e3-9dfa-352f92253881.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN62c1bb9c-79a2-41e3-9dfa-352f9225388119
311994nitrofurantoin macrocrystals 25 MG Oral CapsulePSN62c1bb9c-79a2-41e3-9dfa-352f9225388119
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN62c1bb9c-79a2-41e3-9dfa-352f9225388119
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD62c1bb9c-79a2-41e3-9dfa-352f9225388119
311994nitrofurantoin, macrocrystals 25 MG Oral CapsuleSCD62c1bb9c-79a2-41e3-9dfa-352f9225388119
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD62c1bb9c-79a2-41e3-9dfa-352f9225388119
311994nitrofurantoin macrocrystals 25 MG Oral CapsuleSY62c1bb9c-79a2-41e3-9dfa-352f9225388119
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY62c1bb9c-79a2-41e3-9dfa-352f9225388119
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN29b72c21-ab85-41de-b025-f139e6e13ccc4
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD29b72c21-ab85-41de-b025-f139e6e13ccc4
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY29b72c21-ab85-41de-b025-f139e6e13ccc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-307-0147781030701100 CAPSULE in 1 BOTTLE, PLASTIC (47781-307-01) 100 capsule2010-09-270000-00-00NoNoCurrent