Nitrofurantoin

Product NDC
0591-3686
11-digit product format
005913686
Labeler code
0591
Product ID
0591-3686_203cbe0b-de02-402f-8aeb-1adb0b816866
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA091095
Marketing category
ANDA
Marketing start
2015-10-01
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d02ec8bb-3b28-9b95-8719-8dbb1a2ec5cfProduct name620251106
f6207266-e92b-4b5b-a91b-4af4215c9542Product name620240813
e31776f7-6119-9577-e170-5b569993276eProduct name520240320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3686-01EA - Each0591-3686a7441da5-bf01-42c1-a33d-d65078f0360512015-11-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNcd3af10a-4096-41f5-aec7-cf0d57eabfb64
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDcd3af10a-4096-41f5-aec7-cf0d57eabfb64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3686-0100591368601100 CAPSULE in 1 BOTTLE (0591-3686-01) 100 capsule2015-10-010000-00-00NoNoCurrent
0591-3686-0500591368605500 CAPSULE in 1 BOTTLE (0591-3686-05) 500 capsule2015-10-010000-00-00NoNoCurrent
0591-3686-10005913686101000 CAPSULE in 1 BOTTLE (0591-3686-10) 1000 capsule2015-10-010000-00-00NoNoCurrent
0591-3686-300059136863030 CAPSULE in 1 BOTTLE (0591-3686-30) 30 capsule2015-10-010000-00-00NoNoCurrent
0591-3686-64005913686641250 CAPSULE in 1 BOTTLE (0591-3686-64) 1250 capsule2015-10-010000-00-00NoNoCurrent