Gabapentin

Product NDC
64205-222
11-digit product format
642050222
Labeler code
64205
Product ID
64205-222_978f94ad-3db9-4985-bd67-60e7e8cfe3ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
ReadyMeds
Application
ANDA090705
Marketing category
ANDA
Marketing start
2010-05-17
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64205-222-302019-11-27C16284748780-19855e2a2-3828-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-222-30Gabapentin30 in 1 PACKAGECAPSULE304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [READYMEDS]4
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [READYMEDS]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [READYMEDS]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [READYMEDS]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [READYMEDS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [READYMEDS]4
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [READYMEDS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [READYMEDS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-222GABAPENTIN CAPSULE [READYMEDS]4Legacy NDC, 1 package rows20140701_35fee7b8-c127-4345-bae0-bcf46d3b8ccb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN35fee7b8-c127-4345-bae0-bcf46d3b8ccb4
310431gabapentin 300 MG Oral CapsuleSCD35fee7b8-c127-4345-bae0-bcf46d3b8ccb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-222-306420502223030 in 1 PACKAGEHistorical