FDA.reportPublic FDA data

GABAPENTIN

Product NDC
68788-7024
11-digit product format
687887024
Labeler code
68788
Product ID
68788-7024_7a4c477a-2ba1-48c6-a959-b616343f8cdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090007
Marketing category
ANDA
Marketing start
2020-06-01
Substance
GABAPENTIN
Active strength
300 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
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
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
68788-7024-1GABAPENTIN100 in 1 BOTTLECAPSULE1006
68788-7024-2GABAPENTIN20 in 1 BOTTLECAPSULE206
68788-7024-3GABAPENTIN30 in 1 BOTTLECAPSULE306
68788-7024-4GABAPENTIN28 in 1 BOTTLECAPSULE286
68788-7024-6GABAPENTIN60 in 1 BOTTLECAPSULE606
68788-7024-8GABAPENTIN120 in 1 BOTTLECAPSULE1206
68788-7024-9GABAPENTIN90 in 1 BOTTLECAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7024-1EA - Each68788-702424b7ab7f-9b83-40d0-96f7-75c2e13d51c412021-06-02
68788-7024-3EA - Each68788-7024788b01f6-25a5-4462-a2ae-9d0357e1833b12021-06-02
68788-7024-6EA - Each68788-7024d555010e-d11a-4e13-ae33-8b8321db44cb12021-06-02
68788-7024-8EA - Each68788-7024d4fcc8eb-2943-4e06-bfab-e93769fedd2c12021-06-02
68788-7024-9EA - Each68788-7024ba09c1f6-0f04-443d-ac4b-04e88bb7b16812021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7024GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 7 package rows20240509_11645bd6-7cfe-49b2-9292-2e4b0dbb84ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN11645bd6-7cfe-49b2-9292-2e4b0dbb84ae6
310431gabapentin 300 MG Oral CapsuleSCD11645bd6-7cfe-49b2-9292-2e4b0dbb84ae6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7024-168788702401100 CAPSULE in 1 BOTTLE (68788-7024-1) 100 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-26878870240220 CAPSULE in 1 BOTTLE (68788-7024-2) 20 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-36878870240330 CAPSULE in 1 BOTTLE (68788-7024-3) 30 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-46878870240428 CAPSULE in 1 BOTTLE (68788-7024-4) 28 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-66878870240660 CAPSULE in 1 BOTTLE (68788-7024-6) 60 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-868788702408120 CAPSULE in 1 BOTTLE (68788-7024-8) 120 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-96878870240990 CAPSULE in 1 BOTTLE (68788-7024-9) 90 capsule2020-06-010000-00-00NoNoCurrent