FDA.reportPublic FDA data

Gabapentin

Product NDC
50228-178
11-digit product format
502280178
Labeler code
50228
Product ID
50228-178_176515ec-fdba-417a-b849-86aea6fd7857
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-02-04
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433, 310434

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-178-01Gabapentin100 in 1 BOTTLETABLET10017
50228-178-05Gabapentin500 in 1 BOTTLETABLET50017
50228-178-30Gabapentin30 in 1 BOTTLETABLET3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-178GABAPENTIN TABLET [SCIEGEN PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 3 package rows20241109_5ab9c18b-9568-4dcb-90b0-252aef8f8dc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNd1aa4690-57b5-4a3e-ac12-85f777dbd05e105
310434gabapentin 800 MG Oral TabletPSNa75c9157-a1fc-44cc-89f8-c5a3742fb9ed105
310434gabapentin 800 MG Oral TabletSCDd1aa4690-57b5-4a3e-ac12-85f777dbd05e105
310434gabapentin 800 MG Oral TabletSCDa75c9157-a1fc-44cc-89f8-c5a3742fb9ed105
310434gabapentin 800 MG Oral TabletPSN75caca13-1432-4c0d-8d45-f029b0b2d417101
310434gabapentin 800 MG Oral TabletSCD75caca13-1432-4c0d-8d45-f029b0b2d417101
310433gabapentin 600 MG Oral TabletPSN5ab9c18b-9568-4dcb-90b0-252aef8f8dc217
310434gabapentin 800 MG Oral TabletPSN5ab9c18b-9568-4dcb-90b0-252aef8f8dc217
310433gabapentin 600 MG Oral TabletSCD5ab9c18b-9568-4dcb-90b0-252aef8f8dc217
310434gabapentin 800 MG Oral TabletSCD5ab9c18b-9568-4dcb-90b0-252aef8f8dc217
310430gabapentin 100 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletPSN9b175f8d-7667-4bfe-8bb5-fd7441eed45615
310434gabapentin 800 MG Oral TabletPSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310430gabapentin 100 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletSCD9b175f8d-7667-4bfe-8bb5-fd7441eed45615
310434gabapentin 800 MG Oral TabletSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletPSN5d3f27bf-3486-40fa-a4d3-5f0b2c6c01516
310434gabapentin 800 MG Oral TabletPSN561f53d5-5301-42b3-b372-f3d49d642a2e6
310434gabapentin 800 MG Oral TabletSCD5d3f27bf-3486-40fa-a4d3-5f0b2c6c01516
310434gabapentin 800 MG Oral TabletSCD561f53d5-5301-42b3-b372-f3d49d642a2e6
310434gabapentin 800 MG Oral TabletPSNa8a533f9-59f1-4227-a16b-3f616f1b8bbd4
310434gabapentin 800 MG Oral TabletSCDa8a533f9-59f1-4227-a16b-3f616f1b8bbd4
310434gabapentin 800 MG Oral TabletPSNf1bce199-9f88-4a94-9006-8e148dedd45f3
310434gabapentin 800 MG Oral TabletPSNa9f0852e-0c58-ba22-e053-2995a90adfa03
310434gabapentin 800 MG Oral TabletPSNa9c99dfa-f54d-9207-e053-2995a90ad43b3
310434gabapentin 800 MG Oral TabletPSNc85ae572-9893-629e-e053-2995a90a23fc3
310434gabapentin 800 MG Oral TabletSCDa9c99dfa-f54d-9207-e053-2995a90ad43b3
310434gabapentin 800 MG Oral TabletSCDa9f0852e-0c58-ba22-e053-2995a90adfa03
310434gabapentin 800 MG Oral TabletSCDc85ae572-9893-629e-e053-2995a90a23fc3
310434gabapentin 800 MG Oral TabletSCDf1bce199-9f88-4a94-9006-8e148dedd45f3
310434gabapentin 800 MG Oral TabletPSN2b76955c-52a4-4026-b286-3da1112fe9892
310434gabapentin 800 MG Oral TabletSCD2b76955c-52a4-4026-b286-3da1112fe9892
310434gabapentin 800 MG Oral TabletPSN9d544944-ea95-42e1-8c65-9e442437f0ee1
310434gabapentin 800 MG Oral TabletPSNaf62bb7e-162e-4e2a-8eb0-d50f666787071
310434gabapentin 800 MG Oral TabletPSN3133fc78-dd7a-880c-e063-6394a90a89e11
310434gabapentin 800 MG Oral TabletSCD9d544944-ea95-42e1-8c65-9e442437f0ee1
310434gabapentin 800 MG Oral TabletSCDaf62bb7e-162e-4e2a-8eb0-d50f666787071
310434gabapentin 800 MG Oral TabletSCD3133fc78-dd7a-880c-e063-6394a90a89e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-178-0150228017801100 TABLET in 1 BOTTLE (50228-178-01) 100 tablet2018-08-200000-00-00NoNoCurrent
50228-178-0550228017805500 TABLET in 1 BOTTLE (50228-178-05) 500 tablet2016-02-040000-00-00NoNoCurrent
50228-178-305022801783030 TABLET in 1 BOTTLE (50228-178-30) 30 tablet2016-02-040000-00-00NoNoCurrent