Pregabalin

Product NDC
50090-6504
11-digit product format
500906504
Labeler code
50090
Product ID
50090-6504_c157e81f-3496-4b3f-8b18-4919e67c3ec6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209357
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
200 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483446

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
50090-6504-0Pregabalin60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6504-0EA - Each50090-6504e9a58f7a-b4a3-41aa-897c-976b8963606e12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6504PREGABALIN CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230608_5d33e9c7-6d81-485b-bf4a-9a588eda5208.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483446pregabalin 200 MG Oral CapsulePSN5d33e9c7-6d81-485b-bf4a-9a588eda52083
483446pregabalin 200 MG Oral CapsuleSCD5d33e9c7-6d81-485b-bf4a-9a588eda52083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6504-05009065040060 CAPSULE in 1 BOTTLE (50090-6504-0) 60 capsule2023-05-26NoNoHistorical