Pregabalin

Product NDC
70518-4272
11-digit product format
705184272
Labeler code
70518
Product ID
70518-4272_4019097b-176b-5735-e063-6394a90a1c29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206912
Marketing category
ANDA
Marketing start
2025-01-31
Substance
PREGABALIN
Active strength
25 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483442

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
70518-4272-0Pregabalin30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4272PREGABALIN CAPSULE [REMEDYREPACK INC.]1Current NDC, 1 package rows20250206_e897d7e8-2743-4512-8417-375cb11ceec6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483442pregabalin 25 MG Oral CapsulePSNe897d7e8-2743-4512-8417-375cb11ceec62
483442pregabalin 25 MG Oral CapsuleSCDe897d7e8-2743-4512-8417-375cb11ceec62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4272-07051842720030 CAPSULE in 1 BLISTER PACK (70518-4272-0) 30 capsule2025-01-31NoNoHistorical