Pregabalin

Product NDC
71205-323
11-digit product format
712050323
Labeler code
71205
Product ID
71205-323_f2254c8e-9903-4b30-b6c8-0a0be4e4041b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-19
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
71205-323-30Pregabalin30 in 1 BOTTLECAPSULE304
71205-323-60Pregabalin60 in 1 BOTTLECAPSULE604
71205-323-90Pregabalin90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-323PREGABALIN CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20230204_920c57e0-ddfe-4750-b353-5f96b65443cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN920c57e0-ddfe-4750-b353-5f96b65443cf4
483438pregabalin 100 MG Oral CapsuleSCD920c57e0-ddfe-4750-b353-5f96b65443cf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-323-307120503233030 CAPSULE in 1 BOTTLE (71205-323-30) 30 capsule2019-09-010000-00-00NoNoCurrent
71205-323-607120503236060 CAPSULE in 1 BOTTLE (71205-323-60) 60 capsule2019-09-010000-00-00NoNoCurrent
71205-323-907120503239090 CAPSULE in 1 BOTTLE (71205-323-90) 90 capsule2019-09-010000-00-00NoNoCurrent