Nitrofurantion Macrocrystals

Product NDC
63187-245
11-digit product format
631870245
Labeler code
63187
Product ID
63187-245_63156793-74b0-444c-bb12-dbe7be60ec91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantion Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA016620
Marketing category
NDA
Marketing start
2010-09-27
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 Macrocrystals
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-245-10Nitrofurantion Macrocrystals10 in 1 BOTTLE, PLASTICCAPSULE106
63187-245-14Nitrofurantion Macrocrystals14 in 1 BOTTLE, PLASTICCAPSULE146
63187-245-20Nitrofurantion Macrocrystals20 in 1 BOTTLE, PLASTICCAPSULE206
63187-245-28Nitrofurantion Macrocrystals28 in 1 BOTTLE, PLASTICCAPSULE286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-245-28EA - Each63187-24518a21ba3-297c-4fde-8950-d2363072458b12022-03-09

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-245NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20231111_3b53f9bf-866a-4cb1-9180-7b13896e26ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN3b53f9bf-866a-4cb1-9180-7b13896e26ba6
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD3b53f9bf-866a-4cb1-9180-7b13896e26ba6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-245-106318702451010 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-10) 10 capsule2014-09-010000-00-00NoNoCurrent
63187-245-146318702451414 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-14) 14 capsule2016-09-010000-00-00NoNoCurrent
63187-245-206318702452020 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-20) 20 capsule2014-09-010000-00-00NoNoCurrent
63187-245-286318702452828 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-28) 28 capsule2021-12-080000-00-00NoNoCurrent