FDA.reportPublic FDA data

Pregabalin

Product NDC
70518-2763
11-digit product format
705182763
Labeler code
70518
Product ID
70518-2763_4a8ec75e-3221-744d-e063-6394a90a3846
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209357
Marketing category
ANDA
Marketing start
2020-06-04
Substance
PREGABALIN
Active strength
200 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
PREGABALIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483446

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2763-02022-02-02C16284748780-1d6a99b39-fc7a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004
70518-2763-02022-01-28C16284748780-1d6a99b39-fc7a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2763-0Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE909
70518-2763-1Pregabalin30 in 1 BLISTER PACKCAPSULE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2763PREGABALIN CAPSULE [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 2 package rows20250402_91edbe87-cd22-43a5-9952-1cd523b13820.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483446pregabalin 200 MG Oral CapsulePSN91edbe87-cd22-43a5-9952-1cd523b138209
483446pregabalin 200 MG Oral CapsuleSCD91edbe87-cd22-43a5-9952-1cd523b138209

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2763-07051827630090 CAPSULE in 1 BOTTLE, PLASTIC (70518-2763-0) 90 capsule2020-06-040000-00-00NoNoCurrent
70518-2763-17051827630130 CAPSULE in 1 BLISTER PACK (70518-2763-1) 30 capsule2023-03-10NoNoHistorical