Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
70934-269
11-digit product format
709340269
Labeler code
70934
Product ID
70934-269_af4b89d7-69be-5497-e053-2995a90a3150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA077066
Marketing category
ANDA
Marketing start
2019-02-14
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-269-10EA - Each70934-269690e5b9a-9fd4-4bfb-b731-f651bdf18d2012023-01-09
70934-269-14EA - Each70934-269e23b7ad6-aee5-4163-a588-9d55431e1a0e12023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-269-02709340269022 CAPSULE in 1 BOTTLE, PLASTIC (70934-269-02) 2 capsule2019-02-140000-00-00NoNoCurrent
70934-269-107093402691010 CAPSULE in 1 BOTTLE, PLASTIC (70934-269-10) 10 capsule2019-10-170000-00-00NoNoCurrent
70934-269-147093402691414 CAPSULE in 1 BOTTLE, PLASTIC (70934-269-14) 14 capsule2019-02-140000-00-00NoNoCurrent