FDA.reportPublic FDA data

Pregabalin

Product NDC
71205-639
11-digit product format
712050639
Labeler code
71205
Product ID
71205-639_9cf457c7-9f98-43bc-9ab7-dfea6754ce70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207799
Marketing category
ANDA
Marketing start
2019-07-21
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-639-30Pregabalin30 in 1 BOTTLECAPSULE302
71205-639-60Pregabalin60 in 1 BOTTLECAPSULE602
71205-639-90Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-639-30EA - Each71205-63978f3c494-ae22-45b5-bb9c-af2e13a28ac212022-06-06
71205-639-60EA - Each71205-639cdc6b7ca-ba57-4c60-8956-e5e4bb02af6212022-08-04
71205-639-90EA - Each71205-6398f706096-cace-45e4-8763-ef66b457342812022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-639PREGABALIN CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220513_1503dd3b-688b-4702-8fc1-954b5ffe4235.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN1503dd3b-688b-4702-8fc1-954b5ffe42352
483438pregabalin 100 MG Oral CapsuleSCD1503dd3b-688b-4702-8fc1-954b5ffe42352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-639-307120506393030 CAPSULE in 1 BOTTLE (71205-639-30) 30 capsule2022-02-140000-00-00NoNoCurrent
71205-639-607120506396060 CAPSULE in 1 BOTTLE (71205-639-60) 60 capsule2022-02-140000-00-00NoNoCurrent
71205-639-907120506399090 CAPSULE in 1 BOTTLE (71205-639-90) 90 capsule2022-02-140000-00-00NoNoCurrent