FDA.reportPublic FDA data

Pregabalin

Product NDC
76420-096
11-digit product format
764200096
Labeler code
76420
Product ID
76420-096_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
50 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
PREGABALIN50 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
76420-096-30Pregabalin30 in 1 BOTTLECAPSULE302
76420-096-60Pregabalin60 in 1 BOTTLECAPSULE602
76420-096-90Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-096-30EA - Each76420-09676850f3a-8be1-4adf-b3ea-bba4fa3dfa1b12021-01-08
76420-096-60EA - Each76420-0968a790fa5-eb3c-4f62-a831-9e747a525cf812021-01-08
76420-096-90EA - Each76420-096045f21d6-48ff-4d72-9bdd-0c47af08751812021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-096PREGABALIN 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
76420-096-307642000963030 CAPSULE in 1 BOTTLE (76420-096-30) 30 capsule2020-06-170000-00-00NoNoCurrent
76420-096-607642000966060 CAPSULE in 1 BOTTLE (76420-096-60) 60 capsule2020-06-170000-00-00NoNoCurrent
76420-096-907642000969090 CAPSULE in 1 BOTTLE (76420-096-90) 90 capsule2020-06-170000-00-00NoNoCurrent