FDA.reportPublic FDA data

GABAPENTIN

Product NDC
61919-982
11-digit product format
619190982
Labeler code
61919
Product ID
61919-982_861db26c-c96c-2177-e053-2991aa0ab04a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090705
Marketing category
ANDA
Marketing start
2015-01-01
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
No
Listing certified through
2020-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-982-30GABAPENTIN30 in 1 BOTTLECAPSULE308
61919-982-60GABAPENTIN60 in 1 BOTTLECAPSULE608
61919-982-72GABAPENTIN120 in 1 BOTTLECAPSULE1208
61919-982-90GABAPENTIN90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-982-30EA - Each61919-982afbcd2b1-061d-4e54-b562-86fd61e6d83c12015-12-02
61919-982-60EA - Each61919-982090684c5-5920-4d4e-b01a-99c9dbb4aa6312016-01-13
61919-982-72EA - Each61919-982933b09ed-746b-4296-8b88-7760d96f5a6c12015-12-02
61919-982-90EA - Each61919-982522c1a68-a6f4-4591-96e9-c684e49f952d12015-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-982GABAPENTIN CAPSULE [DIRECT RX]7Legacy NDC, 4 package rows20240111_29a70e2d-d3fd-4e32-95dd-7ee721d87388.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN29a70e2d-d3fd-4e32-95dd-7ee721d873888
310431gabapentin 300 MG Oral CapsuleSCD29a70e2d-d3fd-4e32-95dd-7ee721d873888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-982-306191909823030 CAPSULE in 1 BOTTLE (61919-982-30) 30 capsule2015-01-010000-00-00NoNoCurrent
61919-982-606191909826060 CAPSULE in 1 BOTTLE (61919-982-60) 60 capsule2015-01-010000-00-00NoNoCurrent
61919-982-7261919098272120 CAPSULE in 1 BOTTLE (61919-982-72) 120 capsule2015-01-010000-00-00NoNoCurrent
61919-982-906191909829090 CAPSULE in 1 BOTTLE (61919-982-90) 90 capsule2015-01-010000-00-00NoNoCurrent