Nitrofurantoin Macrocrystals

Product NDC
42254-070
11-digit product format
422540070
Labeler code
42254
Product ID
42254-070_407a8f85-11c4-4404-8678-1c5e68860c8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA073652
Marketing category
ANDA
Marketing start
2011-09-19
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
2017-12-31
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
42254-070-142019-09-24C16284748780-19350213a-3d6d-c013-e053-90daa90a1393NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2131

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-070-14Nitrofurantoin Macrocrystals14 in 1 BOTTLECAPSULE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-070-14EA - Each42254-070a805466e-86dc-478b-892b-11e447d80edf12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-070NITROFURANTOIN MACROCRYSTALS CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120420_407a8f85-11c4-4404-8678-1c5e68860c8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN407a8f85-11c4-4404-8678-1c5e68860c8f1
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD407a8f85-11c4-4404-8678-1c5e68860c8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-070-144225400701414 in 1 BOTTLEHistorical