FDA.reportPublic FDA data

GABAPENTIN

Product NDC
64380-869
11-digit product format
643800869
Labeler code
64380
Product ID
64380-869_1a530f38-ba87-4707-8d04-16be59ae34a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA211314
Marketing category
ANDA
Marketing start
2018-10-17
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN400 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
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
64380-869-06GABAPENTIN100 in 1 BOTTLECAPSULE10010
64380-869-07GABAPENTIN500 in 1 BOTTLECAPSULE50010
64380-869-08GABAPENTIN1000 in 1 BOTTLECAPSULE100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-869-06EA - Each64380-869a3c775e5-85c4-415f-bd1e-58892dfcbf8712019-10-07
64380-869-07EA - Each64380-869995c9df4-dccc-46e2-9ce1-19c7f8f22ae512019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-869GABAPENTIN CAPSULE [STRIDES PHARMA SCIENCE LIMITED]7Current NDC, Legacy NDC, 3 package rows20250129_43b67ae3-ac6f-48f5-8788-9ead08376864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN43b67ae3-ac6f-48f5-8788-9ead0837686410
310431gabapentin 300 MG Oral CapsulePSN43b67ae3-ac6f-48f5-8788-9ead0837686410
310432gabapentin 400 MG Oral CapsulePSN43b67ae3-ac6f-48f5-8788-9ead0837686410
310430gabapentin 100 MG Oral CapsuleSCD43b67ae3-ac6f-48f5-8788-9ead0837686410
310431gabapentin 300 MG Oral CapsuleSCD43b67ae3-ac6f-48f5-8788-9ead0837686410
310432gabapentin 400 MG Oral CapsuleSCD43b67ae3-ac6f-48f5-8788-9ead0837686410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-869-0664380086906100 CAPSULE in 1 BOTTLE (64380-869-06) 100 capsule2018-10-170000-00-00NoNoCurrent
64380-869-0764380086907500 CAPSULE in 1 BOTTLE (64380-869-07) 500 capsule2018-10-170000-00-00NoNoCurrent
64380-869-08643800869081000 CAPSULE in 1 BOTTLE (64380-869-08)1000 capsule2026-06-010Current