Pregabalin

Product NDC
71335-1791
11-digit product format
713351791
Labeler code
71335
Product ID
71335-1791_9d3d3197-6d87-41f8-8d79-c11a7e0d0737
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206912
Marketing category
ANDA
Marketing start
2019-10-08
Substance
PREGABALIN
Active strength
25 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
PREGABALIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483442

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
71335-1791-1Pregabalin30 in 1 BOTTLECAPSULE30104
71335-1791-2Pregabalin60 in 1 BOTTLECAPSULE60104
71335-1791-3Pregabalin90 in 1 BOTTLECAPSULE90104
71335-1791-4Pregabalin15 in 1 BOTTLECAPSULE15104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1791-2EA - Each71335-1791aecefca2-4140-4fbc-b6c7-380000c7438d12023-12-05
71335-1791-3EA - Each71335-1791c207b0b1-d48b-4918-ab08-1f8cc61b4a3612024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1791PREGABALIN (PREGABALIN) CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 4 package rows20240824_fac0eb4e-12ef-4e8e-8cbe-c43c26f0faee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483442pregabalin 25 MG Oral CapsulePSNfac0eb4e-12ef-4e8e-8cbe-c43c26f0faee104
483442pregabalin 25 MG Oral CapsuleSCDfac0eb4e-12ef-4e8e-8cbe-c43c26f0faee104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1791-17133517910130 CAPSULE in 1 BOTTLE (71335-1791-1) 30 capsule2021-09-140000-00-00NoNoCurrent
71335-1791-27133517910260 CAPSULE in 1 BOTTLE (71335-1791-2) 60 capsule2022-03-150000-00-00NoNoCurrent
71335-1791-37133517910390 CAPSULE in 1 BOTTLE (71335-1791-3) 90 capsule2021-03-090000-00-00NoNoCurrent
71335-1791-47133517910415 CAPSULE in 1 BOTTLE (71335-1791-4) 15 capsule2024-08-12NoNoHistorical