FDA.reportPublic FDA data

Gabapentin

Product NDC
51407-048
11-digit product format
514070048
Labeler code
51407
Product ID
51407-048_4aa8dcd6-952c-bebb-e063-6294a90af962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
Marketing end
2026-07-31
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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-048-10Gabapentin1000 in 1 BOTTLE, PLASTICCAPSULE100011
51407-048-18Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE18011
51407-048-27Gabapentin270 in 1 BOTTLE, PLASTICCAPSULE27011
51407-048-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE3011
51407-048-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE6011
51407-048-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-048-10EA - Each51407-048ed04a113-2326-4c69-8529-bede5c471ba012018-11-06
51407-048-18EA - Each51407-04865edb81c-b0fd-472c-bf26-3eb638a491c212018-11-06
51407-048-27EA - Each51407-0489c8b569b-b396-41f6-b7d3-b70166e102fc12018-11-06
51407-048-30EA - Each51407-048411c665f-dfe6-4b7c-9a14-5c03c7b8b3ef12018-11-06
51407-048-60EA - Each51407-048b047ebc2-bf07-4481-b71a-9dc3bd32a7d712018-11-06
51407-048-90EA - Each51407-04870244739-46ea-4a58-83ac-0eddceff719e12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-048GABAPENTIN CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]9Current NDC, Legacy NDC, 6 package rows20231227_76f5eff8-698f-2753-e053-2991aa0ae7f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 CapsulePSN41ce952c-6c16-4b5d-adf7-9ea114e63eb35
310431gabapentin 300 MG Oral CapsuleSCD41ce952c-6c16-4b5d-adf7-9ea114e63eb35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-048-10514070048101000 CAPSULE in 1 BOTTLE, PLASTIC (51407-048-10) 1000 capsule2018-09-120000-00-00NoNoCurrent
51407-048-1851407004818180 CAPSULE in 1 BOTTLE, PLASTIC (51407-048-18) 180 capsule2018-09-120000-00-00NoNoCurrent
51407-048-2751407004827270 CAPSULE in 1 BOTTLE, PLASTIC (51407-048-27) 270 capsule2018-09-120000-00-00NoNoCurrent
51407-048-305140700483030 CAPSULE in 1 BOTTLE, PLASTIC (51407-048-30) 30 capsule2018-09-120000-00-00NoNoCurrent
51407-048-605140700486060 CAPSULE in 1 BOTTLE, PLASTIC (51407-048-60) 60 capsule2018-09-120000-00-00NoNoCurrent
51407-048-905140700489090 CAPSULE in 1 BOTTLE, PLASTIC (51407-048-90) 90 capsule2018-09-120000-00-00NoNoCurrent