Nitrofurantion

Product NDC
68001-386
11-digit product format
680010386
Labeler code
68001
Product ID
68001-386_ad020393-1c97-49da-b0f3-d6a9359fb73d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantion
Dosage form
CAPSULE
Route
ORAL
Labeler
BluePoint Labortories
Application
ANDA201722
Marketing category
ANDA
Marketing start
2019-05-14
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], 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
Nitrofurantion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui311994, 311995, 1648759

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
68001-386-00Nitrofurantion100 in 1 BOTTLECAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-386-00EA - Each68001-38610166680-3fae-47c7-ae37-db8ebb3e634812019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-386NITROFURANTION CAPSULE [BLUEPOINT LABORTORIES]1Current NDC, Legacy NDC, 1 package rows20190515_ad020393-1c97-49da-b0f3-d6a9359fb73d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNad020393-1c97-49da-b0f3-d6a9359fb73d1
311994nitrofurantoin macrocrystals 25 MG Oral CapsulePSNad020393-1c97-49da-b0f3-d6a9359fb73d1
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSNad020393-1c97-49da-b0f3-d6a9359fb73d1
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDad020393-1c97-49da-b0f3-d6a9359fb73d1
311994nitrofurantoin, macrocrystals 25 MG Oral CapsuleSCDad020393-1c97-49da-b0f3-d6a9359fb73d1
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCDad020393-1c97-49da-b0f3-d6a9359fb73d1
311994nitrofurantoin macrocrystals 25 MG Oral CapsuleSYad020393-1c97-49da-b0f3-d6a9359fb73d1
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSYad020393-1c97-49da-b0f3-d6a9359fb73d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-386-0068001038600100 CAPSULE in 1 BOTTLE (68001-386-00) 100 capsule2019-05-140000-00-00NoNoCurrent