GABAPENTIN

Product NDC
71717-102
11-digit product format
717170102
Labeler code
71717
Product ID
71717-102_66482487-88f7-8406-e053-2991aa0a637b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Megalith Pharmaceuticals Inc
Application
ANDA207057
Marketing category
ANDA
Marketing start
2018-03-15
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71717-102-10GABAPENTIN100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
71717-102-50GABAPENTIN500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71717-102-10EA - Each71717-1021921c7ab-6d90-45ad-b91c-c2336c005fc412018-03-08
71717-102-50EA - Each71717-102c12a5a82-8df6-47c1-8b86-92e277adb0de12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71717-102GABAPENTIN TABLET, FILM COATED [MEGALITH PHARMACEUTICALS INC]1Legacy NDC, 2 package rows20180315_80bb6d12-823a-4d7c-82c4-1be11dd45c6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN80bb6d12-823a-4d7c-82c4-1be11dd45c6a1
310434gabapentin 800 MG Oral TabletPSN80bb6d12-823a-4d7c-82c4-1be11dd45c6a1
310433gabapentin 600 MG Oral TabletSCD80bb6d12-823a-4d7c-82c4-1be11dd45c6a1
310434gabapentin 800 MG Oral TabletSCD80bb6d12-823a-4d7c-82c4-1be11dd45c6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71717-102-1071717010210100 in 1 BOTTLE, PLASTICHistorical
71717-102-5071717010250500 in 1 BOTTLE, PLASTICHistorical