Pregabalin

Product NDC
70518-4579
11-digit product format
705184579
Labeler code
70518
Product ID
70518-4579_4c494fcb-83ef-9e1e-e063-6294a90ad626
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206942
Marketing category
ANDA
Marketing start
2026-03-04
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
70518-4579-0Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSN4ccb0d75-d7d9-471c-8737-8552e9e57efa2
483450pregabalin 75 MG Oral CapsuleSCD4ccb0d75-d7d9-471c-8737-8552e9e57efa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4579-07051845790090 CAPSULE in 1 BOTTLE, PLASTIC (70518-4579-0) 90 capsule2026-03-04NoNoCurrent