Macrobid

Product NDC
52427-285
11-digit product format
524270285
Labeler code
52427
Product ID
52427-285_83236f78-20ec-6005-4b09-cc2470a1b36a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form
CAPSULE
Route
ORAL
Labeler
Almatica Pharma LLC
Application
NDA020064
Marketing category
NDA
Marketing start
2011-05-31
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25; 75 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], 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
Macrobid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN25 mg/1
NITROFURANTOIN MONOHYDRATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L, E1QI2CQQ1I
Rxcui539712, 1648755

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
52427-285-01Macrobid100 in 1 BOTTLECAPSULE10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52427-285-01EA - Each52427-285eb6c3871-6aeb-4aee-9380-3b3a265ebf7d12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
NITROFURANTOIN MONOHYDRATEACTIVE INGREDIENTE1QI2CQQ1IMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
NITROFURANTOINACTIVE MOIETY927AH8112LMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
CARBOMER 934INACTIVE INGREDIENTZ135WT9208MACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
GELATININACTIVE INGREDIENT2G86QN327LMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
POVIDONEINACTIVE INGREDIENTFZ989GH94EMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
TALCINACTIVE INGREDIENT7SEV7J4R1UMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52427-285MACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA LLC]24Current NDC, Legacy NDC, 1 package rows20241010_8f270a9f-12a1-44d4-bc7e-873613555801.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
539712Macrobid 100 MG Oral CapsulePSN8f270a9f-12a1-44d4-bc7e-87361355580126
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN8f270a9f-12a1-44d4-bc7e-87361355580126
539712nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule [Macrobid]SBD8f270a9f-12a1-44d4-bc7e-87361355580126
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD8f270a9f-12a1-44d4-bc7e-87361355580126
539712Macrobid 100 MG (as nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG) Oral CapsuleSY8f270a9f-12a1-44d4-bc7e-87361355580126
539712Macrobid 100 MG Oral CapsulePSN28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e9
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e9
539712nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule [Macrobid]SBD28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e9
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e9
539712Macrobid 100 MG (as nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG) Oral CapsuleSY28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e9
539712Macrobid 100 MG Oral CapsulePSN718ef4cc-ea45-43c5-9950-be7698f5f2df1
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN718ef4cc-ea45-43c5-9950-be7698f5f2df1
539712nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule [Macrobid]SBD718ef4cc-ea45-43c5-9950-be7698f5f2df1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD718ef4cc-ea45-43c5-9950-be7698f5f2df1
539712Macrobid 100 MG (as nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG) Oral CapsuleSY718ef4cc-ea45-43c5-9950-be7698f5f2df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52427-285-0152427028501100 CAPSULE in 1 BOTTLE (52427-285-01) 100 capsule2011-05-310000-00-00NoNoCurrent