FDA.reportPublic FDA data

Gabapentin

Product NDC
68788-8816
11-digit product format
687888816
Labeler code
68788
Product ID
68788-8816_db57e37f-0a78-4c14-8768-a28bbf9fa0da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2025-01-21
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
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
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310432

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
68788-8816-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1001
68788-8816-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE301
68788-8816-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE601
68788-8816-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1201
68788-8816-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8816-1EA - Each68788-8816ab647774-6f27-4c90-ad95-91ac1cc13a5312025-03-04
68788-8816-3EA - Each68788-881660f1efd5-1e35-4f04-b321-fc824624e40e12025-03-04
68788-8816-6EA - Each68788-8816a0214b71-7709-44e7-9cf8-23400736224b12025-03-04
68788-8816-8EA - Each68788-8816e1d18647-d8d4-4aea-acd7-54242f350aa512025-03-04
68788-8816-9EA - Each68788-8816ffeaf050-0737-4ad0-9b35-1e01b6be5d4612025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8816GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20250123_db57e37f-0a78-4c14-8768-a28bbf9fa0da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSNdb57e37f-0a78-4c14-8768-a28bbf9fa0da1
310432gabapentin 400 MG Oral CapsuleSCDdb57e37f-0a78-4c14-8768-a28bbf9fa0da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8816-168788881601100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8816-1) 100 capsule2025-01-21NoNoHistorical
68788-8816-36878888160330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8816-3) 30 capsule2025-01-21NoNoHistorical
68788-8816-66878888160660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8816-6) 60 capsule2025-01-21NoNoHistorical
68788-8816-868788881608120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8816-8) 120 capsule2025-01-21NoNoHistorical
68788-8816-96878888160990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8816-9) 90 capsule2025-01-21NoNoHistorical