GABAPENTIN

Product NDC
43547-385
11-digit product format
435470385
Labeler code
43547
Product ID
43547-385_287538e6-6170-46b6-b209-6ae74b376b8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-09-30
Marketing end
2022-07-10
Substance
GABAPENTIN
Active strength
400 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
43547-385-10EA - Each43547-385a0e64138-f8b9-4783-bc0e-f3800f2e459312016-11-08
43547-385-50EA - Each43547-3852150a616-4c65-4f3b-80f5-9c1b191425e512016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-385-034354703850330 CAPSULE in 1 BOTTLE (43547-385-03) 30 capsule2016-09-302022-07-10NoNoCurrent
43547-385-1043547038510100 CAPSULE in 1 BOTTLE (43547-385-10) 100 capsule2016-09-302022-07-10NoNoCurrent
43547-385-5043547038550500 CAPSULE in 1 BOTTLE (43547-385-50) 500 capsule2016-09-302022-07-10NoNoCurrent