FDA.reportPublic FDA data

Pregabalin

Product NDC
68788-8360
11-digit product format
687888360
Labeler code
68788
Product ID
68788-8360_582d8992-18e4-4886-bc7d-d668fa763e44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207799
Marketing category
ANDA
Marketing start
2023-02-01
Substance
PREGABALIN
Active strength
100 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8360-1Pregabalin100 in 1 BLISTER PACKCAPSULE1003
68788-8360-3Pregabalin30 in 1 BOTTLECAPSULE303
68788-8360-6Pregabalin60 in 1 BOTTLECAPSULE603
68788-8360-9Pregabalin90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8360-1EA - Each68788-8360a2de4e93-7ff3-4628-96da-ef44891572b012023-03-13
68788-8360-3EA - Each68788-83600f18368d-f411-44a5-8f5a-5ea1a9b19e1412023-03-13
68788-8360-6EA - Each68788-8360b3f5f2f7-529e-4bb0-8662-f1592c79d28412023-03-13
68788-8360-9EA - Each68788-8360a0034c39-c3d0-49c6-9245-80fe99f24f1612023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8360PREGABALIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20240805_e8e272a4-c181-4573-822b-2bb315b6ad37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNe8e272a4-c181-4573-822b-2bb315b6ad373
483438pregabalin 100 MG Oral CapsuleSCDe8e272a4-c181-4573-822b-2bb315b6ad373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8360-168788836001100 CAPSULE in 1 BLISTER PACK (68788-8360-1) 100 capsule2023-02-01NoNoHistorical
68788-8360-36878883600330 CAPSULE in 1 BOTTLE (68788-8360-3) 30 capsule2023-02-01NoNoHistorical
68788-8360-66878883600660 CAPSULE in 1 BOTTLE (68788-8360-6) 60 capsule2023-02-01NoNoHistorical
68788-8360-96878883600990 CAPSULE in 1 BOTTLE (68788-8360-9) 90 capsule2023-02-01NoNoHistorical