GABAPENTIN

Product NDC
43547-389
11-digit product format
435470389
Labeler code
43547
Product ID
43547-389_287538e6-6170-46b6-b209-6ae74b376b8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-11-20
Marketing end
2022-09-23
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
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
43547-389-10EA - Each43547-3895509a43e-909b-4dd6-8dd2-7044b343c57512017-11-06
43547-389-50EA - Each43547-389945d020c-bf85-40fe-92d9-487fa5f704f012016-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-389-1043547038910100 TABLET in 1 BOTTLE (43547-389-10) 100 tablet2016-11-202022-09-23NoNoCurrent
43547-389-5043547038950500 TABLET in 1 BOTTLE (43547-389-50) 500 tablet2016-11-202022-09-23NoNoCurrent