FDA.reportPublic FDA data

Nitrofurantoin Macrocrystals

Product NDC
0440-1866
11-digit product format
004401866
Labeler code
0440
Product ID
0440-1866_079d1cdd-ac23-48d6-b2ea-e19287ff77fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA073652
Marketing category
ANDA
Marketing start
2007-03-08
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-1866-202020-01-31C16284748780-19d75b9d0-a849-f424-e053-dadaa90a57ceNITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-1866-20Nitrofurantoin Macrocrystals20 in 1 BOTTLE, PLASTICCAPSULE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-1866-20EA - Each0440-1866dcb76f0f-6b2f-472f-9093-054ad750618d12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ONITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-1866NITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20140405_41b65a12-25d4-4e29-ae00-010df78b73ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN41b65a12-25d4-4e29-ae00-010df78b73ed2
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD41b65a12-25d4-4e29-ae00-010df78b73ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-1866-200044018662020 in 1 BOTTLE, PLASTICHistorical