Pregabalin

Product NDC
71205-556
11-digit product format
712050556
Labeler code
71205
Product ID
71205-556_f58c99d0-e792-46b7-a67c-c6b1bce50946
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
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
71205-556-30Pregabalin30 in 1 BOTTLECAPSULE302
71205-556-60Pregabalin60 in 1 BOTTLECAPSULE602
71205-556-90Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-556-30EA - Each71205-556e6d95feb-b40f-407c-a7fd-1073d29cb1f312021-06-02
71205-556-60EA - Each71205-55654727a34-cd5f-4880-b9c0-fa648e60420212022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-556PREGABALIN CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220701_89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b2
483448pregabalin 50 MG Oral CapsuleSCD89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-556-307120505563030 CAPSULE in 1 BOTTLE (71205-556-30) 30 capsule2021-04-230000-00-00NoNoCurrent
71205-556-607120505566060 CAPSULE in 1 BOTTLE (71205-556-60) 60 capsule2021-04-230000-00-00NoNoCurrent
71205-556-907120505569090 CAPSULE in 1 BOTTLE (71205-556-90) 90 capsule2021-04-230000-00-00NoNoCurrent