FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
70756-412
11-digit product format
707560412
Labeler code
70756
Product ID
70756-412_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
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
nitrofurantoin macrocrystals
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-412-11nitrofurantoin macrocrystals100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-412-11EA - Each70756-4121431691e-64b6-45fa-a7b6-9c368308d5ad12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-412NITROFURANTOIN 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 CapsulePSN4bac93c7-dd35-4f5a-8067-5c6fcccc729d100
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD4bac93c7-dd35-4f5a-8067-5c6fcccc729d100
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNf28d72be-56d7-467f-a3f8-9ffd57d0dffa7
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDf28d72be-56d7-467f-a3f8-9ffd57d0dffa7
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN27f2ed1a-d4c2-4c12-92a6-3d0e9ce7f6a16
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD27f2ed1a-d4c2-4c12-92a6-3d0e9ce7f6a16
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN075fe819-fc4f-2dce-e063-6294a90ad8235
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD075fe819-fc4f-2dce-e063-6294a90ad8235
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN00ca617f-d939-a1c8-e063-6394a90a0e543
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNef7053f3-3081-49c4-9c78-d40a01177fd93
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN10d05283-e247-4e60-e063-6294a90ac2923
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDef7053f3-3081-49c4-9c78-d40a01177fd93
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD10d05283-e247-4e60-e063-6294a90ac2923
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD00ca617f-d939-a1c8-e063-6394a90a0e543
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
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN42a1c744-93dc-31cc-e063-6294a90ab9121
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD42a1c744-93dc-31cc-e063-6294a90ab9121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-412-1170756041211100 CAPSULE in 1 BOTTLE (70756-412-11) 100 capsule2023-03-21NoNoHistorical