Nitrofurantoin

Product NDC
60687-633
11-digit product format
606870633
Labeler code
60687
Product ID
60687-633_dc24d3d1-c8f4-58d6-e053-2a95a90a6fb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin monohydrate/macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA207372
Marketing category
ANDA
Marketing start
2022-04-04
Marketing end
0000-00-00
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-633-01EA - Each60687-63364cfe532-8f33-4ba1-a5fd-d62a08a93c2412022-09-12
60687-633-11EA - Each60687-633e9440b90-ab15-4330-a63e-4e66c5b9902712022-09-12
60687-633-65EA - Each60687-63387a3141e-3f9a-477b-9f26-9ab1a6f08e9112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-633NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]4Legacy NDC20250328_cbbab15e-f4ec-4455-b577-58caaa7915e8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-633-0160687063301100 BLISTER PACK in 1 CARTON (60687-633-01) > 1 CAPSULE in 1 BLISTER PACK (60687-633-11) 100 blister pack2022-04-040000-00-00NoNoCurrent