Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
68071-5076
11-digit product format
680715076
Labeler code
68071
Product ID
68071-5076_bbb7a4cb-3b47-5548-e053-2995a90a4f3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077066
Marketing category
ANDA
Marketing start
2005-04-06
Marketing end
0000-00-00
Substance
NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active strength
75 mg/1; mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5076-76807150760714 CAPSULE in 1 BOTTLE (68071-5076-7) 14 capsule2019-10-010000-00-00NoNoCurrent