nitrofurantoin macrocrystals

Product NDC
68071-4688
11-digit product format
680714688
Labeler code
68071
Product ID
68071-4688_bb8bc444-d1e7-a08f-e053-2a95a90a4446
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA205005
Marketing category
ANDA
Marketing start
2018-02-15
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
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
68071-4688-76807146880714 CAPSULE in 1 BOTTLE (68071-4688-7) 14 capsule2019-01-020000-00-00NoNoCurrent