Nitrofurantoin Macrocrystals

Product NDC
70518-2602
11-digit product format
705182602
Labeler code
70518
Product ID
70518-2602_d6aab86a-e4ee-59b4-e053-2995a90a2b90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA073652
Marketing category
ANDA
Marketing start
2020-02-26
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
927AH8112LNITROFURANTOIN67-20-9NITROFURANTOIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2602-07051826020014 CAPSULE in 1 BOTTLE, PLASTIC (70518-2602-0) 14 capsule2020-02-260000-00-00NoNoCurrent