FDA.reportPublic FDA data

Pregabalin

Product NDC
53401-007
11-digit product format
534010007
Labeler code
53401
Product ID
53401-007_4ffdeea2-0b32-7965-e063-6394a90a59d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208677
Marketing category
ANDA
Marketing start
2025-12-10
Substance
PREGABALIN
Active strength
50 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
PREGABALIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483448

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
53401-007-30Pregabalin30 in 1 BOTTLECAPSULE303
53401-007-46Pregabalin56 in 1 BOTTLECAPSULE563
53401-007-53Pregabalin60 in 1 BOTTLECAPSULE603
53401-007-70Pregabalin120 in 1 BOTTLECAPSULE1203
53401-007-75Pregabalin150 in 1 BOTTLECAPSULE1503
53401-007-80Pregabalin180 in 1 BOTTLECAPSULE1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53401-007-30EA - Each53401-007565c30e7-c42d-4d31-b8e9-b172e426304912026-05-22
53401-007-53EA - Each53401-007155204f3-9f64-4227-9453-24af0c9ace6912026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN4ef59b1c-1273-5e54-e063-6294a90a0ec93
483448pregabalin 50 MG Oral CapsuleSCD4ef59b1c-1273-5e54-e063-6294a90a0ec93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53401-007-305340100073030 CAPSULE in 1 BOTTLE (53401-007-30) 30 capsule2026-04-07NoNoHistorical
53401-007-465340100074656 CAPSULE in 1 BOTTLE (53401-007-46) 56 capsule2026-04-15NoNoHistorical
53401-007-535340100075360 CAPSULE in 1 BOTTLE (53401-007-53) 60 capsule2026-04-07NoNoHistorical
53401-007-7053401000770120 CAPSULE in 1 BOTTLE (53401-007-70) 120 capsule2026-04-21NoNoHistorical
53401-007-7553401000775150 CAPSULE in 1 BOTTLE (53401-007-75) 150 capsule2026-04-21NoNoHistorical
53401-007-8053401000780180 CAPSULE in 1 BOTTLE (53401-007-80) 180 capsule2026-04-21NoNoHistorical