FDA.reportPublic FDA data

Gabapentin

Product NDC
68788-8712
11-digit product format
687888712
Labeler code
68788
Product ID
68788-8712_c22a5d36-9f6e-41bf-8703-7364aaa84715
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2024-07-09
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431

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
68788-8712-0Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1003
68788-8712-2Gabapentin20 in 1 BOTTLE, PLASTICCAPSULE203
68788-8712-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE303
68788-8712-4Gabapentin28 in 1 BOTTLE, PLASTICCAPSULE283
68788-8712-5Gabapentin15 in 1 BOTTLE, PLASTICCAPSULE153
68788-8712-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE603
68788-8712-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1203
68788-8712-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8712-0EA - Each68788-8712fd9d032d-3716-46ac-a09d-986e61d01d3212024-09-09
68788-8712-2EA - Each68788-87122eecfd0e-feef-4b3f-ae55-e37f4a5ca4b112024-09-09
68788-8712-3EA - Each68788-8712f02c6147-4bf6-4a59-8447-d5b7fd93c16712024-09-09
68788-8712-4EA - Each68788-871290c46639-d628-46f3-aadb-ed77c3c6657112024-09-09
68788-8712-5EA - Each68788-8712ec51afb3-8687-4017-827f-328f806c4a9c12024-09-09
68788-8712-6EA - Each68788-8712d51f055a-8ad7-4dfc-90f9-dc2e05c443b712024-09-09
68788-8712-8EA - Each68788-8712e8f42734-7a83-4094-8fdf-910515668fac12024-09-09
68788-8712-9EA - Each68788-8712fb86eeac-94ac-4904-9479-92b38354e2c512024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8712GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]1Current NDC, 8 package rows20240713_41dcc917-68d1-49f0-8223-44c21ca259ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN41dcc917-68d1-49f0-8223-44c21ca259ef3
310431gabapentin 300 MG Oral CapsuleSCD41dcc917-68d1-49f0-8223-44c21ca259ef3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8712-068788871200100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-0) 100 capsule2024-07-09NoNoHistorical
68788-8712-26878887120220 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-2) 20 capsule2024-07-09NoNoHistorical
68788-8712-36878887120330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-3) 30 capsule2024-07-09NoNoHistorical
68788-8712-46878887120428 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-4) 28 capsule2024-07-09NoNoHistorical
68788-8712-56878887120515 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-5) 15 capsule2024-07-09NoNoHistorical
68788-8712-66878887120660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-6) 60 capsule2024-07-09NoNoHistorical
68788-8712-868788871208120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-8) 120 capsule2024-07-09NoNoHistorical
68788-8712-96878887120990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-9) 90 capsule2024-07-09NoNoHistorical