Nitrofurantoin Macrocrystals

Product NDC
60687-850
11-digit product format
606870850
Labeler code
60687
Product ID
60687-850_1702f6a9-7bc3-2221-e063-6294a90a96e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA217272
Marketing category
ANDA
Marketing start
2024-04-28
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
Rxcui311995, 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
60687-850-01Nitrofurantoin Macrocrystals100 in 1 CARTONCAPSULE1001
60687-850-11Nitrofurantoin Macrocrystals1 in 1 BLISTER PACKCAPSULE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-850-01EA - Each60687-8500395a15f-aac4-4133-b8a4-2cffb06e89ed12024-05-16
60687-850-11EA - Each60687-850f6ba51f3-55bc-44e6-b2ea-6e08055f49c812024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-850NITROFURANTOIN MACROCRYSTALS CAPSULE [AMERICAN HEALTH PACKAGING]1Current NDC, 2 package rows20240428_ce4afef1-22c1-4a1c-a102-a32fb6a2e045.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNce4afef1-22c1-4a1c-a102-a32fb6a2e0451
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSNce4afef1-22c1-4a1c-a102-a32fb6a2e0451
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDce4afef1-22c1-4a1c-a102-a32fb6a2e0451
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCDce4afef1-22c1-4a1c-a102-a32fb6a2e0451
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSYce4afef1-22c1-4a1c-a102-a32fb6a2e0451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-850-0160687085001100 BLISTER PACK in 1 CARTON (60687-850-01) / 1 CAPSULE in 1 BLISTER PACK (60687-850-11) 100 blister pack2024-04-28NoNoHistorical
60687-850-11606870850111 in 1 BLISTER PACKHistorical