FDA.reportPublic FDA data

Gabapentin

Product NDC
68788-7838
11-digit product format
687887838
Labeler code
68788
Product ID
68788-7838_6c72b1ad-d187-4fdb-af30-7b79aafc2e49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2021-01-18
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
Rxcui310432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7838-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1005
68788-7838-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE305
68788-7838-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE605
68788-7838-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1205
68788-7838-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7838-1EA - Each68788-7838f287f921-6fe9-4c53-ae90-0ec21269317f12021-03-02
68788-7838-3EA - Each68788-7838632e2823-a18e-4f5b-b018-9933bbeb7f7812021-03-02
68788-7838-6EA - Each68788-7838b68c7805-42a4-4a53-b2e2-cac98ea29ecc12021-03-02
68788-7838-8EA - Each68788-78388d7c7cff-6d7e-4f9b-b06d-1295fb41c68912021-03-02
68788-7838-9EA - Each68788-7838a5c1666d-61cd-491f-ac89-7d148cee17c312021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7838GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 5 package rows20240119_100ff86c-56a8-4770-9db3-b9bc6b1bd2f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN100ff86c-56a8-4770-9db3-b9bc6b1bd2f75
310432gabapentin 400 MG Oral CapsuleSCD100ff86c-56a8-4770-9db3-b9bc6b1bd2f75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7838-168788783801100 CAPSULE in 1 BOTTLE, PLASTIC (68788-7838-1) 100 capsule2021-01-180000-00-00NoNoCurrent
68788-7838-36878878380330 CAPSULE in 1 BOTTLE, PLASTIC (68788-7838-3) 30 capsule2021-01-180000-00-00NoNoCurrent
68788-7838-66878878380660 CAPSULE in 1 BOTTLE, PLASTIC (68788-7838-6) 60 capsule2021-01-180000-00-00NoNoCurrent
68788-7838-868788783808120 CAPSULE in 1 BOTTLE, PLASTIC (68788-7838-8) 120 capsule2021-01-180000-00-00NoNoCurrent
68788-7838-96878878380990 CAPSULE in 1 BOTTLE, PLASTIC (68788-7838-9) 90 capsule2021-01-180000-00-00NoNoCurrent