Gabapentin

Product NDC
63304-629
11-digit product format
633040629
Labeler code
63304
Product ID
63304-629_3ac31363-4eb4-4333-ba7f-fc2db7b42439
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA076606
Marketing category
ANDA
Marketing start
2005-11-02
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-629-01Gabapentin100 in 1 BOTTLECAPSULE1005
63304-629-05Gabapentin500 in 1 BOTTLECAPSULE5005
63304-629-30Gabapentin30 in 1 BOTTLECAPSULE305
63304-629-51Gabapentin1 in 1 BLISTER PACKCAPSULE15
63304-629-51Gabapentin50 in 1 CARTONCAPSULE505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-629-01EA - Each63304-6299908b81c-41a1-4cdc-8039-e10e901b5bd512015-10-02
63304-629-05EA - Each63304-629865525d3-9559-40e1-a106-bf15f6c126bf12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-629GABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5Legacy NDC, 5 package rows20140317_0936a88f-b569-49c4-951b-14e8f6273b53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN0936a88f-b569-49c4-951b-14e8f6273b535
310431gabapentin 300 MG Oral CapsulePSN0936a88f-b569-49c4-951b-14e8f6273b535
310432gabapentin 400 MG Oral CapsulePSN0936a88f-b569-49c4-951b-14e8f6273b535
310430gabapentin 100 MG Oral CapsuleSCD0936a88f-b569-49c4-951b-14e8f6273b535
310431gabapentin 300 MG Oral CapsuleSCD0936a88f-b569-49c4-951b-14e8f6273b535
310432gabapentin 400 MG Oral CapsuleSCD0936a88f-b569-49c4-951b-14e8f6273b535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-629-0163304062901100 in 1 BOTTLEHistorical
63304-629-0563304062905500 in 1 BOTTLEHistorical
63304-629-306330406293030 in 1 BOTTLEHistorical
63304-629-51633040629511 in 1 BLISTER PACKHistorical