FDA.reportPublic FDA data

Pregabalin

Product NDC
71335-1789
11-digit product format
713351789
Labeler code
71335
Product ID
71335-1789_509a0a9e-1158-48c0-bb8c-c2ece3a3cc4a
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
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

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
71335-1789-1Pregabalin30 in 1 BOTTLECAPSULE30106
71335-1789-2Pregabalin90 in 1 BOTTLECAPSULE90106
71335-1789-3Pregabalin60 in 1 BOTTLECAPSULE60106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1789-1EA - Each71335-1789442c6b82-b8af-4fd2-a28e-34608b0ac05212022-04-06
71335-1789-2EA - Each71335-178943298dcc-4a60-4a3b-b3e2-02013a68943612022-10-06
71335-1789-3EA - Each71335-1789c8ff0dc2-84d1-47cf-bdc7-4159a71d60c212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1789PREGABALIN (PREGABALIN) CAPSULE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 3 package rows20250406_aac1f2f4-5ef5-49dd-b914-54f2cf2b1bc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNaac1f2f4-5ef5-49dd-b914-54f2cf2b1bc1106
483438pregabalin 100 MG Oral CapsuleSCDaac1f2f4-5ef5-49dd-b914-54f2cf2b1bc1106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1789-17133517890130 CAPSULE in 1 BOTTLE (71335-1789-1) 30 capsule2021-03-100000-00-00NoNoCurrent
71335-1789-27133517890290 CAPSULE in 1 BOTTLE (71335-1789-2) 90 capsule2021-03-080000-00-00NoNoCurrent
71335-1789-37133517890360 CAPSULE in 1 BOTTLE (71335-1789-3) 60 capsule2021-03-110000-00-00NoNoCurrent