nitrofurantoin macrocrystals

Product NDC
43063-400
11-digit product format
430630400
Labeler code
43063
Product ID
43063-400_e71734e0-1bb7-c66e-e053-2995a90a7b9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA016620
Marketing category
NDA
Marketing start
2010-09-27
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-400-02EA - Each43063-40044bbcc47-ced3-43ba-8bc8-f76c7e85960112017-05-03
43063-400-10EA - Each43063-400ac51d096-5eea-4b67-a559-9f0bd5b2e49e12013-05-02
43063-400-12EA - Each43063-4008c1c5b72-11a5-4e5b-88e9-3f2435a739ff12013-05-02
43063-400-14EA - Each43063-400980adbcb-5c86-4f11-9b61-db1efea1eed112016-11-08
43063-400-20EA - Each43063-400bb561b44-548f-4670-b828-e3f83d0ca69112013-05-02
43063-400-40EA - Each43063-400d8d20105-9e27-452b-a244-464b478bf25912013-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-400-02430630400022 CAPSULE in 1 BOTTLE, PLASTIC (43063-400-02) 2 capsule2011-06-130000-00-00NoNoCurrent
43063-400-104306304001010 CAPSULE in 1 BOTTLE, PLASTIC (43063-400-10) 10 capsule2011-06-130000-00-00NoNoCurrent
43063-400-124306304001212 CAPSULE in 1 BOTTLE, PLASTIC (43063-400-12) 12 capsule2011-06-130000-00-00NoNoCurrent
43063-400-144306304001414 CAPSULE in 1 BOTTLE, PLASTIC (43063-400-14) 14 capsule2011-06-130000-00-00NoNoCurrent
43063-400-204306304002020 CAPSULE in 1 BOTTLE, PLASTIC (43063-400-20) 20 capsule2011-06-130000-00-00NoNoCurrent
43063-400-284306304002828 CAPSULE in 1 BOTTLE, PLASTIC (43063-400-28) 28 capsule2011-06-130000-00-00NoNoCurrent
43063-400-304306304003030 CAPSULE in 1 BOTTLE, PLASTIC (43063-400-30) 30 capsule2011-06-130000-00-00NoNoCurrent
43063-400-404306304004040 CAPSULE in 1 BOTTLE, PLASTIC (43063-400-40) 40 capsule2011-06-130000-00-00NoNoCurrent