FDA.reportPublic FDA data

Nitrofurantoin Macrocrystals

Product NDC
61919-842
11-digit product format
619190842
Labeler code
61919
Product ID
61919-842_4c4a0cbe-75d9-ecfa-e063-6394a90aeb28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA217272
Marketing category
ANDA
Marketing start
2024-02-07
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantoin Macrocrystals
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui1648759

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
61919-842-14Nitrofurantoin Macrocrystals14 in 1 BOTTLECAPSULE143
61919-842-20Nitrofurantoin Macrocrystals20 in 1 BOTTLECAPSULE203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-842-20EA - Each61919-842f5eeb02e-e850-4571-9bcf-9a94b51aea0812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-842NITROFURANTOIN MACROCRYSTALS CAPSULE [DIRECT_RX]2Current NDC, 2 package rows20240208_10d05283-e247-4e60-e063-6294a90ac292.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN10d05283-e247-4e60-e063-6294a90ac2923
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD10d05283-e247-4e60-e063-6294a90ac2923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61919-842-146191908421414 CAPSULE in 1 BOTTLE (61919-842-14) 14 capsule2024-02-07NoNoHistorical
61919-842-206191908422020 CAPSULE in 1 BOTTLE (61919-842-20) 20 capsule2024-02-07NoNoHistorical