FDA.reportPublic FDA data

Pregabalin

Product NDC
13668-365
11-digit product format
136680365
Labeler code
13668
Product ID
13668-365_f28a120a-aea5-45b9-84f7-06f48f41bc03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA206942
Marketing category
ANDA
Marketing start
2025-05-19
Substance
PREGABALIN
Active strength
300 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN300 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
13668-365-01Pregabalin100 in 1 BOTTLECAPSULE10012
13668-365-02Pregabalin200 in 1 BOTTLECAPSULE20012
13668-365-05Pregabalin500 in 1 BOTTLECAPSULE50012
13668-365-30Pregabalin30 in 1 BOTTLECAPSULE3012
13668-365-60Pregabalin60 in 1 BOTTLECAPSULE6012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-365PREGABALIN CAPSULE [TORRENT PHARMACEUTICALS LIMITED]10Current NDC, 5 package rows20250520_a062e78a-16ff-4d83-b700-0badb7d812d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483440pregabalin 150 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483446pregabalin 200 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
577127pregabalin 225 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483442pregabalin 25 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483444pregabalin 300 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483448pregabalin 50 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483450pregabalin 75 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483438pregabalin 100 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483440pregabalin 150 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483446pregabalin 200 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
577127pregabalin 225 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483442pregabalin 25 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483444pregabalin 300 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483448pregabalin 50 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483450pregabalin 75 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-365-0113668036501100 CAPSULE in 1 BOTTLE (13668-365-01) 100 capsule2025-05-19NoNoCurrent
13668-365-0213668036502200 CAPSULE in 1 BOTTLE (13668-365-02) 200 capsule2025-05-19NoNoCurrent
13668-365-0513668036505500 CAPSULE in 1 BOTTLE (13668-365-05) 500 capsule2025-05-19NoNoCurrent
13668-365-301366803653030 CAPSULE in 1 BOTTLE (13668-365-30) 30 capsule2025-05-19NoNoCurrent
13668-365-601366803656060 CAPSULE in 1 BOTTLE (13668-365-60) 60 capsule2025-05-19NoNoCurrent