FDA.reportPublic FDA data

Gabapentin

Product NDC
68788-8489
11-digit product format
687888489
Labeler code
68788
Product ID
68788-8489_51748ab8-e69d-43a0-9a44-033937e12a64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2023-07-21
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430

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
68788-8489-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1004
68788-8489-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE304
68788-8489-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE604
68788-8489-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1204
68788-8489-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8489-1EA - Each68788-8489e8c210c2-95c9-4d15-b674-a2e5ed43cd5b12023-09-05
68788-8489-3EA - Each68788-8489f7e3cfb1-adc8-4216-abe3-7c5f07d6b57e12023-09-05
68788-8489-6EA - Each68788-8489e47a89b1-3c89-496a-8b4b-c73d20445bb212023-09-05
68788-8489-8EA - Each68788-8489f3536882-3ce0-454d-8bb8-3b1008b806c112023-09-05
68788-8489-9EA - Each68788-8489ede25e04-9744-457f-99a0-5112ef92798312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8489GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20240504_e3429322-c442-4146-bb68-bcc3a8d01552.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNe3429322-c442-4146-bb68-bcc3a8d015524
310430gabapentin 100 MG Oral CapsuleSCDe3429322-c442-4146-bb68-bcc3a8d015524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8489-168788848901100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8489-1) 100 capsule2023-07-21NoNoHistorical
68788-8489-36878884890330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8489-3) 30 capsule2023-07-21NoNoHistorical
68788-8489-66878884890660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8489-6) 60 capsule2023-07-21NoNoHistorical
68788-8489-868788848908120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8489-8) 120 capsule2023-07-21NoNoHistorical
68788-8489-96878884890990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8489-9) 90 capsule2023-07-21NoNoHistorical