Pregabalin

Product NDC
60760-485
11-digit product format
607600485
Labeler code
60760
Product ID
60760-485_51cb55ec-931d-6f5d-e063-6294a90aefb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-09-03
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
60760-485-30Pregabalin30 in 1 BOTTLE, PLASTICCAPSULE309
60760-485-60Pregabalin60 in 1 BOTTLE, PLASTICCAPSULE609
60760-485-90Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-485PREGABALIN CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]5Current NDC, Legacy NDC, 3 package rows20231209_923743f0-f557-9143-e053-2a95a90a21ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSN923743f0-f557-9143-e053-2a95a90a21ae9
483450pregabalin 75 MG Oral CapsuleSCD923743f0-f557-9143-e053-2a95a90a21ae9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-485-306076004853030 CAPSULE in 1 BOTTLE, PLASTIC (60760-485-30) 30 capsule2025-12-290000-00-00NoNoCurrent
60760-485-606076004856060 CAPSULE in 1 BOTTLE, PLASTIC (60760-485-60) 60 capsule2019-09-030000-00-00NoNoCurrent
60760-485-906076004859090 CAPSULE in 1 BOTTLE, PLASTIC (60760-485-90) 90 capsule2019-09-100000-00-00NoNoCurrent