FDA.reportPublic FDA data

Pregabalin

Product NDC
70518-2525
11-digit product format
705182525
Labeler code
70518
Product ID
70518-2525_4ba93e72-1a6d-6633-e063-6394a90a33a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209357
Marketing category
ANDA
Marketing start
2020-01-06
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2525-02022-01-30C16284748780-1d6a99b39-ed0f-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
70518-2525-02022-01-30C16284748780-1d6a99b39-ed0f-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
70518-2525-02022-01-28C16284748780-1d6a99b39-ed0f-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
70518-2525-02022-01-28C16284748780-1d6a99b39-ed0f-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
70518-2525-0Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE9012
70518-2525-1Pregabalin60 in 1 BOTTLE, PLASTICCAPSULE6012
70518-2525-2Pregabalin30 in 1 BLISTER PACKCAPSULE3012
70518-2525-3Pregabalin30 in 1 BOTTLE, PLASTICCAPSULE3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2525PREGABALIN CAPSULE [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 4 package rows20250316_5290f7ad-6660-45ff-853d-6dcb947b570d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSN5290f7ad-6660-45ff-853d-6dcb947b570d12
483450pregabalin 75 MG Oral CapsuleSCD5290f7ad-6660-45ff-853d-6dcb947b570d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2525-07051825250090 CAPSULE in 1 BOTTLE, PLASTIC (70518-2525-0) 90 capsule2020-01-060000-00-00NoNoCurrent
70518-2525-17051825250160 CAPSULE in 1 BOTTLE, PLASTIC (70518-2525-1) 60 capsule2022-11-250000-00-00NoNoCurrent
70518-2525-27051825250230 CAPSULE in 1 BLISTER PACK (70518-2525-2) 30 capsule2023-03-10NoNoCurrent
70518-2525-37051825250330 CAPSULE in 1 BOTTLE, PLASTIC (70518-2525-3) 30 capsule2026-02-25NoNoCurrent