Gabapentin

Product NDC
63187-056
11-digit product format
631870056
Labeler code
63187
Product ID
63187-056_75599dc3-b3a3-440f-b052-6e980c297c93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090705
Marketing category
ANDA
Marketing start
2010-05-17
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
No
Listing certified through
2022-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-056-90EA - Each63187-05649acf5f6-9ecd-44f9-9702-6b58af57ba8612016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [PROFICIENT RX LP]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [PROFICIENT RX LP]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [PROFICIENT RX LP]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [PROFICIENT RX LP]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [PROFICIENT RX LP]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [PROFICIENT RX LP]7
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [PROFICIENT RX LP]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [PROFICIENT RX LP]7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-056-306318700563030 CAPSULE in 1 BOTTLE (63187-056-30) 30 capsule2019-01-010000-00-00NoNoCurrent
63187-056-606318700566060 CAPSULE in 1 BOTTLE (63187-056-60) 60 capsule2019-01-010000-00-00NoNoCurrent
63187-056-7263187005672120 CAPSULE in 1 BOTTLE (63187-056-72) 120 capsule2019-01-010000-00-00NoNoCurrent
63187-056-906318700569090 CAPSULE in 1 BOTTLE (63187-056-90) 90 capsule2019-01-010000-00-00NoNoCurrent