Gabapentin

Product NDC
31722-221
11-digit product format
317220221
Labeler code
31722
Product ID
31722-221_edc0e13b-6531-4233-a98c-42a06ce94c37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals Inc.
Application
ANDA090705
Marketing category
ANDA
Marketing start
2010-05-17
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
100 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-221-01EA - Each31722-2216ee7fc02-e2a2-4d40-a6c4-3a6301a98f9b12012-07-24
31722-221-05EA - Each31722-221ff411c50-cd51-4068-aa69-6b7180cfa33112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [PROFICIENT RX LP]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [PROFICIENT RX LP]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [PROFICIENT RX LP]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [PROFICIENT RX LP]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [PROFICIENT RX LP]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [PROFICIENT RX LP]7
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [PROFICIENT RX LP]7
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [PROFICIENT RX LP]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [CAMBER PHARMACEUTICALS INC.]6
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [CAMBER PHARMACEUTICALS INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [CAMBER PHARMACEUTICALS INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [CAMBER PHARMACEUTICALS INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [CAMBER PHARMACEUTICALS INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [CAMBER PHARMACEUTICALS INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [CAMBER PHARMACEUTICALS INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [CAMBER PHARMACEUTICALS INC.]6
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]5
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]5
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]5
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-221GABAPENTIN CAPSULE [CAMBER PHARMACEUTICALS INC.]6Legacy NDC20151017_501e8d07-bfc3-4427-b7d5-93c4d5874ab4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNa2109f51-f1e5-4ba5-b3b1-3e3ebee6cf1d9
310430gabapentin 100 MG Oral CapsuleSCDa2109f51-f1e5-4ba5-b3b1-3e3ebee6cf1d9
310430gabapentin 100 MG Oral CapsulePSN783d8373-b7af-4a6b-8966-50c5ddb2803b5
310431gabapentin 300 MG Oral CapsulePSN783d8373-b7af-4a6b-8966-50c5ddb2803b5
310430gabapentin 100 MG Oral CapsuleSCD783d8373-b7af-4a6b-8966-50c5ddb2803b5
310431gabapentin 300 MG Oral CapsuleSCD783d8373-b7af-4a6b-8966-50c5ddb2803b5
310430gabapentin 100 MG Oral CapsulePSN99adb2c7-4725-4768-a2d9-856a87f331921
310430gabapentin 100 MG Oral CapsuleSCD99adb2c7-4725-4768-a2d9-856a87f331921