FDA.reportPublic FDA data

Pregabalin

Product NDC
76420-100
11-digit product format
764200100
Labeler code
76420
Product ID
76420-100_ead3b1c9-5c7d-457b-e053-2995a90a71ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
200 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
PREGABALIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127

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
76420-100-30Pregabalin30 in 1 BOTTLECAPSULE302
76420-100-60Pregabalin60 in 1 BOTTLECAPSULE602
76420-100-90Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-100-30EA - Each76420-1005b9fd65c-80b8-4b5f-bd9b-8d7e782869f812021-01-08
76420-100-60EA - Each76420-100581aff47-2f67-4d91-ad18-e68c2d63e27012021-01-08
76420-100-90EA - Each76420-1006f42389c-b8c6-4aa4-b95a-c49e576487f112021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-100PREGABALIN CAPSULE [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 3 package rows20221013_3d2464fb-b3ac-496e-b8a5-c2e8a902ce29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483446pregabalin 200 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
577127pregabalin 225 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483444pregabalin 300 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483450pregabalin 75 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483438pregabalin 100 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483446pregabalin 200 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
577127pregabalin 225 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483444pregabalin 300 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483450pregabalin 75 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-100-307642001003030 CAPSULE in 1 BOTTLE (76420-100-30) 30 capsule2020-06-170000-00-00NoNoCurrent
76420-100-607642001006060 CAPSULE in 1 BOTTLE (76420-100-60) 60 capsule2020-06-170000-00-00NoNoCurrent
76420-100-907642001009090 CAPSULE in 1 BOTTLE (76420-100-90) 90 capsule2020-06-170000-00-00NoNoCurrent