Nitrofurantion

Product NDC
68071-2647
11-digit product format
680712647
Labeler code
68071
Product ID
68071-2647_d8c68797-47a8-2956-e053-2a95a90a0149
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantion
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA201722
Marketing category
ANDA
Marketing start
2016-04-15
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2647-4Nitrofurantion4 in 1 BOTTLECAPSULE41
68071-2647-6Nitrofurantion6 in 1 BOTTLECAPSULE61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2647NITROFURANTION CAPSULE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220225_d8c68797-47a9-2956-e053-2a95a90a0149.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNd8c68797-47a9-2956-e053-2a95a90a01491
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDd8c68797-47a9-2956-e053-2a95a90a01491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2647-4680712647044 CAPSULE in 1 BOTTLE (68071-2647-4) 4 capsule2022-02-240000-00-00NoNoCurrent
68071-2647-6680712647066 CAPSULE in 1 BOTTLE (68071-2647-6) 6 capsule2022-02-240000-00-00NoNoCurrent