FDA.reportPublic FDA data

Pregabalin

Product NDC
71335-1751
11-digit product format
713351751
Labeler code
71335
Product ID
71335-1751_89f62416-4795-41ff-b6ff-58c8f092b82a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207799
Marketing category
ANDA
Marketing start
2019-10-02
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
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
71335-1751-1Pregabalin30 in 1 BOTTLECAPSULE30102
71335-1751-2Pregabalin60 in 1 BOTTLECAPSULE60102
71335-1751-3Pregabalin90 in 1 BOTTLECAPSULE90102
71335-1751-4Pregabalin15 in 1 BOTTLECAPSULE15102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1751-3EA - Each71335-1751a97293d2-0e25-4fc8-875e-85e549a4599712025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1751PREGABALIN CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20240915_4cda70e8-9ae1-4958-8c86-1bc633be982b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN4cda70e8-9ae1-4958-8c86-1bc633be982b102
483448pregabalin 50 MG Oral CapsuleSCD4cda70e8-9ae1-4958-8c86-1bc633be982b102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1751-17133517510130 CAPSULE in 1 BOTTLE (71335-1751-1) 30 capsule2020-12-230000-00-00NoNoCurrent
71335-1751-27133517510260 CAPSULE in 1 BOTTLE (71335-1751-2) 60 capsule2021-05-240000-00-00NoNoCurrent
71335-1751-37133517510390 CAPSULE in 1 BOTTLE (71335-1751-3) 90 capsule2021-01-110000-00-00NoNoCurrent
71335-1751-47133517510415 CAPSULE in 1 BOTTLE (71335-1751-4) 15 capsule2024-09-06NoNoCurrent