FDA.reportPublic FDA data

Gabapentin

Product NDC
50228-180
11-digit product format
502280180
Labeler code
50228
Product ID
50228-180_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
300 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
GABAPENTIN300 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
50228-180-01Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE10015
50228-180-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE50015
50228-180-10Gabapentin1000 in 1 BOTTLE, PLASTICCAPSULE100015
50228-180-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-180GABAPENTIN CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 4 package rows20231109_16542ee6-0e0e-4d3c-8b32-60ff6ef48846.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN691205ba-fa65-4bc9-ba20-7d361382cff9105
310431gabapentin 300 MG Oral CapsulePSN2ac0622c-440a-49a0-974f-726e6ac72a0e105
310431gabapentin 300 MG Oral CapsuleSCD691205ba-fa65-4bc9-ba20-7d361382cff9105
310431gabapentin 300 MG Oral CapsuleSCD2ac0622c-440a-49a0-974f-726e6ac72a0e105
310431gabapentin 300 MG Oral CapsulePSN1af098ad-28b5-463f-8efa-24d70a77d64c101
310431gabapentin 300 MG Oral CapsuleSCD1af098ad-28b5-463f-8efa-24d70a77d64c101
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
310431gabapentin 300 MG Oral CapsulePSNe877a425-2b7f-4e43-a1f9-24019cbf968510
310431gabapentin 300 MG Oral CapsuleSCDe877a425-2b7f-4e43-a1f9-24019cbf968510
310430gabapentin 100 MG Oral CapsulePSNed3a0d48-2e98-44ee-8743-880d1221a4806
310431gabapentin 300 MG Oral CapsulePSNed3a0d48-2e98-44ee-8743-880d1221a4806
310430gabapentin 100 MG Oral CapsuleSCDed3a0d48-2e98-44ee-8743-880d1221a4806
310431gabapentin 300 MG Oral CapsuleSCDed3a0d48-2e98-44ee-8743-880d1221a4806
310431gabapentin 300 MG Oral CapsulePSNed9cb5fe-7a2e-e0bc-e053-2a95a90a44704
310431gabapentin 300 MG Oral CapsulePSNa36ffbd9-a6d0-120a-e053-2995a90a9eac4
310431gabapentin 300 MG Oral CapsulePSNb56ce49e-7c73-2cc9-e053-2995a90a4ab84
310431gabapentin 300 MG Oral CapsulePSNbff3beea-1f05-4e84-bcd2-d05782acddae4
310431gabapentin 300 MG Oral CapsulePSNd294f6aa-ed82-90a2-e053-2995a90a28964
310431gabapentin 300 MG Oral CapsuleSCDa36ffbd9-a6d0-120a-e053-2995a90a9eac4
310431gabapentin 300 MG Oral CapsuleSCDb56ce49e-7c73-2cc9-e053-2995a90a4ab84
310431gabapentin 300 MG Oral CapsuleSCDbff3beea-1f05-4e84-bcd2-d05782acddae4
310431gabapentin 300 MG Oral CapsuleSCDd294f6aa-ed82-90a2-e053-2995a90a28964
310431gabapentin 300 MG Oral CapsuleSCDed9cb5fe-7a2e-e0bc-e053-2a95a90a44704
310430gabapentin 100 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsulePSN54c09aa5-6724-480a-a115-c88484e39e933
310431gabapentin 300 MG Oral CapsulePSN25befbfa-5125-4363-8306-f862e81c0a6f3
310431gabapentin 300 MG Oral CapsulePSN41dcc917-68d1-49f0-8223-44c21ca259ef3
310432gabapentin 400 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310430gabapentin 100 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsuleSCD41dcc917-68d1-49f0-8223-44c21ca259ef3
310431gabapentin 300 MG Oral CapsuleSCD25befbfa-5125-4363-8306-f862e81c0a6f3
310431gabapentin 300 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsuleSCD54c09aa5-6724-480a-a115-c88484e39e933
310432gabapentin 400 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsulePSN1749d731-bc8c-4374-b2a9-7c809c457f562
310431gabapentin 300 MG Oral CapsulePSNb7a29b99-ce23-950e-e053-2995a90a19342
310431gabapentin 300 MG Oral CapsulePSNbd5c9279-a1e3-2a59-e053-2a95a90a33a22
310431gabapentin 300 MG Oral CapsulePSN1b44a3ab-4d06-205f-e063-6294a90af3682
310431gabapentin 300 MG Oral CapsuleSCDb7a29b99-ce23-950e-e053-2995a90a19342
310431gabapentin 300 MG Oral CapsuleSCD1749d731-bc8c-4374-b2a9-7c809c457f562
310431gabapentin 300 MG Oral CapsuleSCD1b44a3ab-4d06-205f-e063-6294a90af3682
310431gabapentin 300 MG Oral CapsuleSCDbd5c9279-a1e3-2a59-e053-2a95a90a33a22
310431gabapentin 300 MG Oral CapsulePSNc300bb3e-a556-4094-9114-6f9ecff2d77c1
310431gabapentin 300 MG Oral CapsulePSN1b73e9db-eddb-49ba-9778-01d39ece4d161
310431gabapentin 300 MG Oral CapsulePSN4f95c01f-200e-bfd7-e063-6394a90abc381
310431gabapentin 300 MG Oral CapsulePSN12f0c2ee-9a44-9778-e063-6294a90a3b581
310431gabapentin 300 MG Oral CapsuleSCD1b73e9db-eddb-49ba-9778-01d39ece4d161
310431gabapentin 300 MG Oral CapsuleSCDc300bb3e-a556-4094-9114-6f9ecff2d77c1
310431gabapentin 300 MG Oral CapsuleSCD4f95c01f-200e-bfd7-e063-6394a90abc381
310431gabapentin 300 MG Oral CapsuleSCD12f0c2ee-9a44-9778-e063-6294a90a3b581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-180-0150228018001100 CAPSULE in 1 BOTTLE, PLASTIC (50228-180-01) 100 capsule2018-08-200000-00-00NoNoCurrent
50228-180-0550228018005500 CAPSULE in 1 BOTTLE, PLASTIC (50228-180-05) 500 capsule2016-02-180000-00-00NoNoCurrent
50228-180-10502280180101000 CAPSULE in 1 BOTTLE, PLASTIC (50228-180-10) 1000 capsule2019-11-140000-00-00NoNoCurrent
50228-180-305022801803030 CAPSULE in 1 BOTTLE, PLASTIC (50228-180-30) 30 capsule2016-02-180000-00-00NoNoCurrent