FDA.reportPublic FDA data

Macrodantin

Product NDC
52427-287
11-digit product format
524270287
Labeler code
52427
Product ID
52427-287_37d894c9-0d78-8459-4007-55c1a006bc2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Almatica Pharma LLC
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
Macrodantin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui201882, 201883, 207791, 311994, 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
52427-287-01Macrodantin100 in 1 BOTTLE, PLASTICCAPSULE10023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52427-287-01EA - Each52427-287f9d80fc5-e238-41a5-a7c2-82a7ee0edaaa12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LMACRODANTIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [ALMATICA PHARMA INC.]12
NITROFURANTOINACTIVE MOIETY927AH8112LMACRODANTIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [ALMATICA PHARMA INC.]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMACRODANTIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [ALMATICA PHARMA INC.]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MACRODANTIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [ALMATICA PHARMA INC.]12
GELATININACTIVE INGREDIENT2G86QN327LMACRODANTIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [ALMATICA PHARMA INC.]12
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMACRODANTIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [ALMATICA PHARMA INC.]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMACRODANTIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [ALMATICA PHARMA INC.]12
TALCINACTIVE INGREDIENT7SEV7J4R1UMACRODANTIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [ALMATICA PHARMA INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMACRODANTIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [ALMATICA PHARMA INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52427-287MACRODANTIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [ALMATICA PHARMA LLC]22Current NDC, Legacy NDC, 1 package rows20241018_89d8696b-f9ce-9691-6222-8416ca143bba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
201883Macrodantin 100 MG Oral CapsulePSN89d8696b-f9ce-9691-6222-8416ca143bba23
207791Macrodantin 25 MG Oral CapsulePSN89d8696b-f9ce-9691-6222-8416ca143bba23
201882Macrodantin 50 MG Oral CapsulePSN89d8696b-f9ce-9691-6222-8416ca143bba23
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN89d8696b-f9ce-9691-6222-8416ca143bba23
311994nitrofurantoin macrocrystals 25 MG Oral CapsulePSN89d8696b-f9ce-9691-6222-8416ca143bba23
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN89d8696b-f9ce-9691-6222-8416ca143bba23
201883nitrofurantoin, macrocrystals 100 MG Oral Capsule [Macrodantin]SBD89d8696b-f9ce-9691-6222-8416ca143bba23
207791nitrofurantoin, macrocrystals 25 MG Oral Capsule [Macrodantin]SBD89d8696b-f9ce-9691-6222-8416ca143bba23
201882nitrofurantoin, macrocrystals 50 MG Oral Capsule [Macrodantin]SBD89d8696b-f9ce-9691-6222-8416ca143bba23
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD89d8696b-f9ce-9691-6222-8416ca143bba23
311994nitrofurantoin, macrocrystals 25 MG Oral CapsuleSCD89d8696b-f9ce-9691-6222-8416ca143bba23
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD89d8696b-f9ce-9691-6222-8416ca143bba23
201883Macrodantin 100 MG Oral CapsuleSY89d8696b-f9ce-9691-6222-8416ca143bba23
207791Macrodantin 25 MG Oral CapsuleSY89d8696b-f9ce-9691-6222-8416ca143bba23
201882Macrodantin 50 MG Oral CapsuleSY89d8696b-f9ce-9691-6222-8416ca143bba23
311994nitrofurantoin macrocrystals 25 MG Oral CapsuleSY89d8696b-f9ce-9691-6222-8416ca143bba23
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY89d8696b-f9ce-9691-6222-8416ca143bba23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52427-287-0152427028701100 CAPSULE in 1 BOTTLE, PLASTIC (52427-287-01) 100 capsule2010-09-270000-00-00NoNoCurrent