Gabapentin

Product NDC
50228-177
11-digit product format
502280177
Labeler code
50228
Product ID
50228-177_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
600 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
GABAPENTIN600 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50228-177-01Gabapentin100 in 1 BOTTLETABLET10017
50228-177-05Gabapentin500 in 1 BOTTLETABLET50017
50228-177-30Gabapentin30 in 1 BOTTLETABLET3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-177GABAPENTIN 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
310433gabapentin 600 MG Oral TabletPSNce0f0d7f-da6d-47da-a4ed-fb8f72902412105
310433gabapentin 600 MG Oral TabletPSNabb56036-88df-4720-ba78-529971671545105
310433gabapentin 600 MG Oral TabletSCDabb56036-88df-4720-ba78-529971671545105
310433gabapentin 600 MG Oral TabletSCDce0f0d7f-da6d-47da-a4ed-fb8f72902412105
310433gabapentin 600 MG Oral TabletPSN56378630-e7a7-4981-8212-8ea703a433d8101
310433gabapentin 600 MG Oral TabletSCD56378630-e7a7-4981-8212-8ea703a433d8101
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
310433gabapentin 600 MG Oral TabletPSNba4d863d-be38-8cf5-e053-2995a90a69fb4
310433gabapentin 600 MG Oral TabletPSNd5c9dd2c-b8ee-1406-e053-2995a90a02874
310433gabapentin 600 MG Oral TabletSCDd5c9dd2c-b8ee-1406-e053-2995a90a02874
310433gabapentin 600 MG Oral TabletSCDba4d863d-be38-8cf5-e053-2995a90a69fb4
310433gabapentin 600 MG Oral TabletPSN2fb2233f-9152-4630-ab39-51a0cda7e5ca3
310433gabapentin 600 MG Oral TabletSCD2fb2233f-9152-4630-ab39-51a0cda7e5ca3
310433gabapentin 600 MG Oral TabletPSN0b917c7a-e2d0-4a76-be4c-134eb5550c0d2
310433gabapentin 600 MG Oral TabletPSN8d55a479-03e0-413e-804a-d1a87b9f4b142
310433gabapentin 600 MG Oral TabletSCD8d55a479-03e0-413e-804a-d1a87b9f4b142
310433gabapentin 600 MG Oral TabletSCD0b917c7a-e2d0-4a76-be4c-134eb5550c0d2
310433gabapentin 600 MG Oral TabletPSNc18d9d06-f796-4eb7-8fd5-1de4ebb954391
310433gabapentin 600 MG Oral TabletPSNf9bf87e4-5499-4dd7-a0c1-16025a718d141
310433gabapentin 600 MG Oral TabletSCDc18d9d06-f796-4eb7-8fd5-1de4ebb954391
310433gabapentin 600 MG Oral TabletSCDf9bf87e4-5499-4dd7-a0c1-16025a718d141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-177-0150228017701100 TABLET in 1 BOTTLE (50228-177-01) 100 tablet2018-08-200000-00-00NoNoCurrent
50228-177-0550228017705500 TABLET in 1 BOTTLE (50228-177-05) 500 tablet2016-02-040000-00-00NoNoCurrent
50228-177-305022801773030 TABLET in 1 BOTTLE (50228-177-30) 30 tablet2016-02-040000-00-00NoNoCurrent