Pregabalin

Product NDC
68788-7656
11-digit product format
687887656
Labeler code
68788
Product ID
68788-7656_8181b922-0398-4e41-a782-db774ec9c05a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA208677
Marketing category
ANDA
Marketing start
2020-02-28
Substance
PREGABALIN
Active strength
300 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
PREGABALIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483444

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
68788-7656-1Pregabalin100 in 1 BOTTLECAPSULE1005
68788-7656-3Pregabalin30 in 1 BOTTLECAPSULE305
68788-7656-6Pregabalin60 in 1 BOTTLECAPSULE605
68788-7656-9Pregabalin90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7656-1EA - Each68788-76562f993b6f-a93e-4903-9856-7aabaee31f6212020-06-05
68788-7656-3EA - Each68788-7656e5d3962e-bfc4-4503-9af6-d99213665e1612020-06-05
68788-7656-6EA - Each68788-7656ea62e45a-6276-4bc4-a234-e7e1a763874612020-06-05
68788-7656-9EA - Each68788-76560747bff1-5614-4527-89db-76486db6945f12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7656PREGABALIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20250119_8c3aedae-9745-4f63-ad64-a643f0245418.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483444pregabalin 300 MG Oral CapsulePSN8c3aedae-9745-4f63-ad64-a643f02454185
483444pregabalin 300 MG Oral CapsuleSCD8c3aedae-9745-4f63-ad64-a643f02454185

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7656-168788765601100 CAPSULE in 1 BOTTLE (68788-7656-1) 100 capsule2020-02-280000-00-00NoNoCurrent
68788-7656-36878876560330 CAPSULE in 1 BOTTLE (68788-7656-3) 30 capsule2020-02-280000-00-00NoNoCurrent
68788-7656-66878876560660 CAPSULE in 1 BOTTLE (68788-7656-6) 60 capsule2020-02-280000-00-00NoNoCurrent
68788-7656-96878876560990 CAPSULE in 1 BOTTLE (68788-7656-9) 90 capsule2020-02-280000-00-00NoNoCurrent