FDA.reportPublic FDA data

Pregabalin

Product NDC
70518-3643
11-digit product format
705183643
Labeler code
70518
Product ID
70518-3643_4f6dfca1-47f0-4a14-e063-6394a90a32dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207799
Marketing category
ANDA
Marketing start
2023-02-15
Substance
PREGABALIN
Active strength
100 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
PREGABALIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438

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
70518-3643-0Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE908
70518-3643-1Pregabalin60 in 1 BOTTLE, PLASTICCAPSULE608
70518-3643-2Pregabalin30 in 1 BLISTER PACKCAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3643-0EA - Each70518-3643a192e7ad-6fbf-410c-a499-b1bc3a0bad0c12026-02-05
70518-3643-1EA - Each70518-3643743f4ae4-c7a0-40d5-8554-17c4bf5b22d012026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3643PREGABALIN CAPSULE [REMEDYREPACK INC.]4Current NDC, 3 package rows20241115_3c8ea6da-5771-4096-a915-700e51ced05c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN3c8ea6da-5771-4096-a915-700e51ced05c8
483438pregabalin 100 MG Oral CapsuleSCD3c8ea6da-5771-4096-a915-700e51ced05c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3643-07051836430090 CAPSULE in 1 BOTTLE, PLASTIC (70518-3643-0) 90 capsule2023-02-15NoNoHistorical
70518-3643-17051836430160 CAPSULE in 1 BOTTLE, PLASTIC (70518-3643-1) 60 capsule2023-02-15NoNoHistorical
70518-3643-27051836430230 in 1 BLISTER PACKHistorical