FDA.reportPublic FDA data

Gabapentin

Product NDC
50228-179
11-digit product format
502280179
Labeler code
50228
Product ID
50228-179_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
100 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
GABAPENTIN100 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
50228-179-01Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE10015
50228-179-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE50015
50228-179-10Gabapentin1000 in 1 BOTTLE, PLASTICCAPSULE100015
50228-179-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-179-01EA - Each50228-1795def89d8-cd4e-496f-b149-a13fae3adaa412019-01-24
50228-179-05EA - Each50228-179dd635eb6-68dd-4d5c-ba3f-9c83d5e31bf612019-01-24
50228-179-10EA - Each50228-179d2d5e4f6-48bc-46e2-850b-55a3e6f506b312021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-179GABAPENTIN 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
310430gabapentin 100 MG Oral CapsulePSN97e47698-97c9-4eb5-a108-5850c2aa2818106
310430gabapentin 100 MG Oral CapsuleSCD97e47698-97c9-4eb5-a108-5850c2aa2818106
310430gabapentin 100 MG Oral CapsulePSNcb81fd89-b32b-4538-bf5c-ab02f65b3458105
310430gabapentin 100 MG Oral CapsuleSCDcb81fd89-b32b-4538-bf5c-ab02f65b3458105
310430gabapentin 100 MG Oral CapsulePSN9a2658d5-9b0e-4921-b4c5-4c89f1630d69101
310430gabapentin 100 MG Oral CapsuleSCD9a2658d5-9b0e-4921-b4c5-4c89f1630d69101
310430gabapentin 100 MG Oral CapsulePSN4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a18
310430gabapentin 100 MG Oral CapsuleSCD4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a18
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
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
310430gabapentin 100 MG Oral CapsulePSNe3429322-c442-4146-bb68-bcc3a8d015524
310430gabapentin 100 MG Oral CapsulePSNd35cd5ac-5ed6-2405-e053-2995a90a69464
310430gabapentin 100 MG Oral CapsuleSCDd35cd5ac-5ed6-2405-e053-2995a90a69464
310430gabapentin 100 MG Oral CapsuleSCDe3429322-c442-4146-bb68-bcc3a8d015524
310430gabapentin 100 MG Oral CapsulePSNb8b7e045-a7fe-8539-e053-2a95a90a40f83
310430gabapentin 100 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310430gabapentin 100 MG Oral CapsulePSN2625c0ef-5295-41de-9e81-88001a6cbecc3
310430gabapentin 100 MG Oral CapsulePSN88ac51c4-5fa9-4c35-9c63-f26bcb101d4b3
310431gabapentin 300 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310432gabapentin 400 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310430gabapentin 100 MG Oral CapsuleSCD2625c0ef-5295-41de-9e81-88001a6cbecc3
310430gabapentin 100 MG Oral CapsuleSCD88ac51c4-5fa9-4c35-9c63-f26bcb101d4b3
310430gabapentin 100 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310430gabapentin 100 MG Oral CapsuleSCDb8b7e045-a7fe-8539-e053-2a95a90a40f83
310431gabapentin 300 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310432gabapentin 400 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310430gabapentin 100 MG Oral CapsulePSN1ead7343-ab25-41b5-af4f-f903470e1dd91
310430gabapentin 100 MG Oral CapsulePSN5073abda-321f-29d1-e063-6394a90a59ac1
310430gabapentin 100 MG Oral CapsulePSN1fdaff2f-ff0e-479e-92b9-5bb93849ca441
310430gabapentin 100 MG Oral CapsulePSN481e6b68-50e4-4594-9815-32580a84ab8c1
310430gabapentin 100 MG Oral CapsulePSN781b0d62-a760-4371-8908-1f61329928a61
310430gabapentin 100 MG Oral CapsuleSCD481e6b68-50e4-4594-9815-32580a84ab8c1
310430gabapentin 100 MG Oral CapsuleSCD5073abda-321f-29d1-e063-6394a90a59ac1
310430gabapentin 100 MG Oral CapsuleSCD1fdaff2f-ff0e-479e-92b9-5bb93849ca441
310430gabapentin 100 MG Oral CapsuleSCD1ead7343-ab25-41b5-af4f-f903470e1dd91
310430gabapentin 100 MG Oral CapsuleSCD781b0d62-a760-4371-8908-1f61329928a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-179-0150228017901100 CAPSULE in 1 BOTTLE, PLASTIC (50228-179-01) 100 capsule2018-08-200000-00-00NoNoCurrent
50228-179-0550228017905500 CAPSULE in 1 BOTTLE, PLASTIC (50228-179-05) 500 capsule2018-08-200000-00-00NoNoCurrent
50228-179-10502280179101000 CAPSULE in 1 BOTTLE, PLASTIC (50228-179-10) 1000 capsule2016-02-180000-00-00NoNoCurrent
50228-179-305022801793030 CAPSULE in 1 BOTTLE, PLASTIC (50228-179-30) 30 capsule2016-02-180000-00-00NoNoCurrent