FDA.reportPublic FDA data

PREGABALIN

Product NDC
72658-0809
11-digit product format
726580809
Labeler code
72658
Product ID
72658-0809_4739c18b-9a48-41df-e063-6394a90a3589
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Eskayef Pharmaceuticals Limited
Application
ANDA212988
Marketing category
ANDA
Marketing start
2022-04-04
Substance
PREGABALIN
Active strength
50 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
PREGABALIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127

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
72658-0809-1PREGABALIN60 in 1 BOTTLECAPSULE609
72658-0809-2PREGABALIN90 in 1 BOTTLECAPSULE909
72658-0809-3PREGABALIN6 in 1 CARTONCAPSULE69
72658-0809-3PREGABALIN10 in 1 BLISTER PACKCAPSULE109
72658-0809-5PREGABALIN10 in 1 CARTONCAPSULE109
72658-0809-5PREGABALIN10 in 1 BLISTER PACKCAPSULE109
72658-0809-6PREGABALIN500 in 1 BOTTLECAPSULE5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72658-0809PREGABALIN CAPSULE [ESKAYEF PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 7 package rows20230809_65d9e751-61c2-4741-85c0-2526cfdc765c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN65d9e751-61c2-4741-85c0-2526cfdc765c9
483440pregabalin 150 MG Oral CapsulePSN65d9e751-61c2-4741-85c0-2526cfdc765c9
483446pregabalin 200 MG Oral CapsulePSN65d9e751-61c2-4741-85c0-2526cfdc765c9
577127pregabalin 225 MG Oral CapsulePSN65d9e751-61c2-4741-85c0-2526cfdc765c9
483442pregabalin 25 MG Oral CapsulePSN65d9e751-61c2-4741-85c0-2526cfdc765c9
483444pregabalin 300 MG Oral CapsulePSN65d9e751-61c2-4741-85c0-2526cfdc765c9
483448pregabalin 50 MG Oral CapsulePSN65d9e751-61c2-4741-85c0-2526cfdc765c9
483450pregabalin 75 MG Oral CapsulePSN65d9e751-61c2-4741-85c0-2526cfdc765c9
483438pregabalin 100 MG Oral CapsuleSCD65d9e751-61c2-4741-85c0-2526cfdc765c9
483440pregabalin 150 MG Oral CapsuleSCD65d9e751-61c2-4741-85c0-2526cfdc765c9
483446pregabalin 200 MG Oral CapsuleSCD65d9e751-61c2-4741-85c0-2526cfdc765c9
577127pregabalin 225 MG Oral CapsuleSCD65d9e751-61c2-4741-85c0-2526cfdc765c9
483442pregabalin 25 MG Oral CapsuleSCD65d9e751-61c2-4741-85c0-2526cfdc765c9
483444pregabalin 300 MG Oral CapsuleSCD65d9e751-61c2-4741-85c0-2526cfdc765c9
483448pregabalin 50 MG Oral CapsuleSCD65d9e751-61c2-4741-85c0-2526cfdc765c9
483450pregabalin 75 MG Oral CapsuleSCD65d9e751-61c2-4741-85c0-2526cfdc765c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72658-0809-17265808090160 CAPSULE in 1 BOTTLE (72658-0809-1) 60 capsule2022-04-040000-00-00NoNoCurrent
72658-0809-27265808090290 CAPSULE in 1 BOTTLE (72658-0809-2) 90 capsule2022-04-040000-00-00NoNoCurrent
72658-0809-3726580809036 BLISTER PACK in 1 CARTON (72658-0809-3) / 10 CAPSULE in 1 BLISTER PACK6 blister pack2022-04-040000-00-00NoNoCurrent
72658-0809-57265808090510 BLISTER PACK in 1 CARTON (72658-0809-5) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2022-04-040000-00-00NoNoCurrent
72658-0809-672658080906500 CAPSULE in 1 BOTTLE (72658-0809-6) 500 capsule2022-04-040000-00-00NoNoCurrent