FDA.reportPublic FDA data

pregabalin

Product NDC
14445-124
11-digit product format
144450124
Labeler code
14445
Product ID
14445-124_522b3d6c-10fb-4581-afb7-2e48150b6048
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA208113
Marketing category
ANDA
Marketing start
2024-05-17
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, 483440, 483442, 483444, 483446, 483448, 483450, 577127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14445-124-00pregabalin1000 in 1 BOTTLECAPSULE10002
14445-124-10pregabalin100 in 1 BLISTER PACKCAPSULE1002
14445-124-90pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-124PREGABALIN CAPSULE [INDOCO REMEDIES LIMITED ]1Current NDC, 3 package rows20240601_0a8d9e35-46fd-4c70-bb7f-4e8b754f2794.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483440pregabalin 150 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483446pregabalin 200 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
577127pregabalin 225 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483442pregabalin 25 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483444pregabalin 300 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483448pregabalin 50 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483450pregabalin 75 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483438pregabalin 100 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483440pregabalin 150 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483446pregabalin 200 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
577127pregabalin 225 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483442pregabalin 25 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483444pregabalin 300 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483448pregabalin 50 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483450pregabalin 75 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14445-124-00144450124001000 CAPSULE in 1 BOTTLE (14445-124-00) 1000 capsule2024-09-06NoNoHistorical
14445-124-1014445012410100 CAPSULE in 1 BLISTER PACK (14445-124-10) 100 capsule2024-05-17NoNoHistorical
14445-124-901444501249090 CAPSULE in 1 BOTTLE (14445-124-90) 90 capsule2024-05-17NoNoHistorical