GABAPENTIN

Product NDC
25000-103
11-digit product format
250000103
Labeler code
25000
Product ID
25000-103_a09d9505-f432-4ed6-b274-3885faffb02a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA090007
Marketing category
ANDA
Marketing start
2011-02-28
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-103-03GABAPENTIN30 in 1 BOTTLECAPSULE3030
25000-103-12GABAPENTIN500 in 1 BOTTLECAPSULE50030
25000-103-14GABAPENTIN1000 in 1 BOTTLECAPSULE100030
25000-103-98GABAPENTIN1 in 1 BOXCAPSULE130
25000-103-98GABAPENTIN55555 in 1 BAGCAPSULE5555530

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-103GABAPENTIN CAPSULE [MARKSANS PHARMA LIMITED]28Current NDC, Legacy NDC, 5 package rows20240810_98bb408d-c402-4da6-8f9d-5de4833dedc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN98bb408d-c402-4da6-8f9d-5de4833dedc430
310431gabapentin 300 MG Oral CapsulePSN98bb408d-c402-4da6-8f9d-5de4833dedc430
310432gabapentin 400 MG Oral CapsulePSN98bb408d-c402-4da6-8f9d-5de4833dedc430
310430gabapentin 100 MG Oral CapsuleSCD98bb408d-c402-4da6-8f9d-5de4833dedc430
310431gabapentin 300 MG Oral CapsuleSCD98bb408d-c402-4da6-8f9d-5de4833dedc430
310432gabapentin 400 MG Oral CapsuleSCD98bb408d-c402-4da6-8f9d-5de4833dedc430

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-103-01250000103014000 CAPSULE in 1 BAG (25000-103-01) 4000 capsule2011-02-280000-00-00NoNoCurrent
25000-103-032500001030330 CAPSULE in 1 BOTTLE (25000-103-03) 30 capsule2011-02-280000-00-00NoNoCurrent
25000-103-1225000010312500 CAPSULE in 1 BOTTLE (25000-103-12) 500 capsule2011-02-280000-00-00NoNoCurrent
25000-103-14250000103141000 CAPSULE in 1 BOTTLE (25000-103-14) 1000 capsule2021-09-160000-00-00NoNoCurrent
25000-103-92250000103921 BAG in 1 BOX (25000-103-92) > 38888 CAPSULE in 1 BAG1 bag2011-02-280000-00-00NoNoCurrent
25000-103-98250000103981 BAG in 1 BOX (25000-103-98) / 55555 CAPSULE in 1 BAG1 bag2011-02-280000-00-00NoNoCurrent