Gabapentin

Product NDC
50228-181
11-digit product format
502280181
Labeler code
50228
Product ID
50228-181_156a9379-da89-427a-9135-b14af9f8787f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-181-01Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE10015
50228-181-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE50015
50228-181-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-181GABAPENTIN CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 3 package rows20231109_16542ee6-0e0e-4d3c-8b32-60ff6ef48846.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN48037fc4-1aab-4ae8-aede-7c55b494877a105
310432gabapentin 400 MG Oral CapsuleSCD48037fc4-1aab-4ae8-aede-7c55b494877a105
310432gabapentin 400 MG Oral CapsulePSN43cbff48-8219-41ba-b67d-3ae4544b78bb101
310432gabapentin 400 MG Oral CapsuleSCD43cbff48-8219-41ba-b67d-3ae4544b78bb101
310430gabapentin 100 MG Oral CapsulePSN16542ee6-0e0e-4d3c-8b32-60ff6ef4884615
310431gabapentin 300 MG Oral CapsulePSN16542ee6-0e0e-4d3c-8b32-60ff6ef4884615
310432gabapentin 400 MG Oral CapsulePSN16542ee6-0e0e-4d3c-8b32-60ff6ef4884615
310430gabapentin 100 MG Oral CapsuleSCD16542ee6-0e0e-4d3c-8b32-60ff6ef4884615
310431gabapentin 300 MG Oral CapsuleSCD16542ee6-0e0e-4d3c-8b32-60ff6ef4884615
310432gabapentin 400 MG Oral CapsuleSCD16542ee6-0e0e-4d3c-8b32-60ff6ef4884615
310430gabapentin 100 MG Oral CapsulePSN76f5eff8-698f-2753-e053-2991aa0ae7f912
310431gabapentin 300 MG Oral CapsulePSN76f5eff8-698f-2753-e053-2991aa0ae7f912
310432gabapentin 400 MG Oral CapsulePSN76f5eff8-698f-2753-e053-2991aa0ae7f912
310430gabapentin 100 MG Oral CapsuleSCD76f5eff8-698f-2753-e053-2991aa0ae7f912
310431gabapentin 300 MG Oral CapsuleSCD76f5eff8-698f-2753-e053-2991aa0ae7f912
310432gabapentin 400 MG Oral CapsuleSCD76f5eff8-698f-2753-e053-2991aa0ae7f912
310432gabapentin 400 MG Oral CapsulePSN100ff86c-56a8-4770-9db3-b9bc6b1bd2f75
310432gabapentin 400 MG Oral CapsuleSCD100ff86c-56a8-4770-9db3-b9bc6b1bd2f75
310432gabapentin 400 MG Oral CapsulePSNdea03ea5-1806-44ab-84e3-42a85f0db9824
310432gabapentin 400 MG Oral CapsuleSCDdea03ea5-1806-44ab-84e3-42a85f0db9824
310430gabapentin 100 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310432gabapentin 400 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310432gabapentin 400 MG Oral CapsulePSNf7a943ec-9a13-45ba-9bc5-18162b86b9213
310430gabapentin 100 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310432gabapentin 400 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310432gabapentin 400 MG Oral CapsuleSCDf7a943ec-9a13-45ba-9bc5-18162b86b9213
310432gabapentin 400 MG Oral CapsulePSN95757436-2093-41cf-a9a9-ef2f28ac096f2
310432gabapentin 400 MG Oral CapsuleSCD95757436-2093-41cf-a9a9-ef2f28ac096f2
310432gabapentin 400 MG Oral CapsulePSNdb57e37f-0a78-4c14-8768-a28bbf9fa0da1
310432gabapentin 400 MG Oral CapsuleSCDdb57e37f-0a78-4c14-8768-a28bbf9fa0da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-181-0150228018101100 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-01) 100 capsule2018-08-200000-00-00NoNoCurrent
50228-181-0550228018105500 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-05) 500 capsule2016-02-180000-00-00NoNoCurrent
50228-181-305022801813030 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-30) 30 capsule2016-02-180000-00-00NoNoCurrent