Pregabalin

Product NDC
60760-753
11-digit product format
607600753
Labeler code
60760
Product ID
60760-753_4b94bfc8-c371-8251-e063-6294a90ad033
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA209357
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
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
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-753-60Pregabalin30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN4b94bfc1-88fc-2b5f-e063-6394a90a70771
483438pregabalin 100 MG Oral CapsuleSCD4b94bfc1-88fc-2b5f-e063-6394a90a70771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-753-606076007536030 CAPSULE in 1 BOTTLE, PLASTIC (60760-753-60) 30 capsule2026-02-24NoNoCurrent