FDA.reportPublic FDA data

Gabapentin

Product NDC
43353-075
11-digit product format
433530075
Labeler code
43353
Product ID
43353-075_c53f4d79-df8d-42b8-86e3-bd6181049abc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075350
Marketing category
ANDA
Marketing start
2010-01-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431, 310432

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-075-30Gabapentin30 in 1 BOTTLECAPSULE301
43353-075-60Gabapentin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-075-30EA - Each43353-0759cefb762-c56d-4547-8852-a74425edaf7b12018-10-11
43353-075-60EA - Each43353-07501b94b34-42b2-4579-afb8-39ee23b1369d12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-075GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20160707_86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491
310432gabapentin 400 MG Oral CapsulePSN86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491
310431gabapentin 300 MG Oral CapsuleSCD86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491
310432gabapentin 400 MG Oral CapsuleSCD86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-075-304335300753030 CAPSULE in 1 BOTTLE (43353-075-30) 30 capsule2015-09-150000-00-00NoNoCurrent
43353-075-604335300756090 CAPSULE in 1 BOTTLE (43353-075-60) 90 capsule2015-07-120000-00-00NoNoCurrent