nitrofurantoin macrocrystals

Product NDC
70756-410
11-digit product format
707560410
Labeler code
70756
Product ID
70756-410_9add55a0-f57d-473d-9e83-ceffe099a1b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-03-21
Substance
NITROFURANTOIN
Active strength
25 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
nitrofurantoin macrocrystals
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN25 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
70756-410-11nitrofurantoin macrocrystals100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-410-11EA - Each70756-410aa006e1e-bcf1-4f95-84eb-8538879b203312023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-410NITROFURANTOIN MACROCRYSTALS CAPSULE [LIFESTAR PHARMA LLC]2Current NDC, 1 package rows20230325_6ec66cc8-938f-4839-98c7-a51c9f1d50ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN6ec66cc8-938f-4839-98c7-a51c9f1d50ed2
311994nitrofurantoin macrocrystals 25 MG Oral CapsulePSN6ec66cc8-938f-4839-98c7-a51c9f1d50ed2
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN6ec66cc8-938f-4839-98c7-a51c9f1d50ed2
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD6ec66cc8-938f-4839-98c7-a51c9f1d50ed2
311994nitrofurantoin, macrocrystals 25 MG Oral CapsuleSCD6ec66cc8-938f-4839-98c7-a51c9f1d50ed2
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD6ec66cc8-938f-4839-98c7-a51c9f1d50ed2
311994nitrofurantoin macrocrystals 25 MG Oral CapsuleSY6ec66cc8-938f-4839-98c7-a51c9f1d50ed2
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY6ec66cc8-938f-4839-98c7-a51c9f1d50ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-410-1170756041011100 CAPSULE in 1 BOTTLE (70756-410-11) 100 capsule2023-03-21NoNoHistorical