Pregabalin

Product NDC
50090-5071
11-digit product format
500905071
Labeler code
50090
Product ID
50090-5071_64f9bdbc-96b6-429e-986e-6a555ab98f38
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
75 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
PREGABALIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483450

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
50090-5071-0Pregabalin90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5071-0EA - Each50090-5071bb54f2ff-067d-4f84-8b3c-49cd9091390112025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5071PREGABALIN CAPSULE [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20231216_fa24fa02-e27d-476a-b6c4-93650aaaee68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSNfa24fa02-e27d-476a-b6c4-93650aaaee689
483450pregabalin 75 MG Oral CapsuleSCDfa24fa02-e27d-476a-b6c4-93650aaaee689

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5071-05009050710090 CAPSULE in 1 BOTTLE (50090-5071-0) 90 capsule2020-06-080000-00-00NoNoCurrent