FDA.reportPublic FDA data

Gabapentin

Product NDC
51407-049
11-digit product format
514070049
Labeler code
51407
Product ID
51407-049_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
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

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
51407-049-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE50011
51407-049-27Gabapentin270 in 1 BOTTLE, PLASTICCAPSULE27011
51407-049-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-049-05EA - Each51407-049ab9706f2-1300-4c61-9fd1-f97a4f1c9ecc12018-11-06
51407-049-27EA - Each51407-0496f7b022a-a781-4679-bedf-81a20a32dbd512018-11-06
51407-049-90EA - Each51407-0498947a8b8-bb5a-49cf-a341-5616ed3a7d3d12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-049GABAPENTIN CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]9Current NDC, Legacy NDC, 3 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
310432gabapentin 400 MG Oral CapsulePSN13b87441-8fe1-40f5-8ffb-00dcd8cc90a64
310432gabapentin 400 MG Oral CapsuleSCD13b87441-8fe1-40f5-8ffb-00dcd8cc90a64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-049-0551407004905500 CAPSULE in 1 BOTTLE, PLASTIC (51407-049-05) 500 capsule2018-09-120000-00-00NoNoCurrent
51407-049-2751407004927270 CAPSULE in 1 BOTTLE, PLASTIC (51407-049-27) 270 capsule2018-09-120000-00-00NoNoCurrent
51407-049-905140700499090 CAPSULE in 1 BOTTLE, PLASTIC (51407-049-90) 90 capsule2018-09-120000-00-00NoNoCurrent