Nitrofurantoin Macrocrystals

Product NDC
67296-0658
11-digit product format
672960658
Labeler code
67296
Product ID
67296-0658_fda7b707-6391-403d-afd8-f825dc76777c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA073652
Marketing category
ANDA
Marketing start
2011-01-10
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
67296-0658-12020-01-31C16284748780-19d75b9d0-cdcf-f424-e053-dadaa90a57ceNITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0658-1Nitrofurantoin Macrocrystals14 in 1 BOTTLECAPSULE141

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0658NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]1Legacy NDC, 1 package rows20110623_dc6bc96c-9a40-469a-9b7c-9cb570b5fd85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNdc6bc96c-9a40-469a-9b7c-9cb570b5fd851
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDdc6bc96c-9a40-469a-9b7c-9cb570b5fd851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0658-16729606580114 in 1 BOTTLEHistorical