Pregabalin

Product NDC
58118-1467
11-digit product format
581181467
Labeler code
58118
Product ID
58118-1467_4ab91bd8-f850-874b-e063-6294a90a94e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA207799
Marketing category
ANDA
Marketing start
2019-07-21
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
Rxcui483438, 483440, 483446, 483448, 483450

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
58118-1467-8Pregabalin30 in 1 BLISTER PACKCAPSULE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483440pregabalin 150 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483446pregabalin 200 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483448pregabalin 50 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483450pregabalin 75 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483438pregabalin 100 MG Oral CapsuleSCD613a7a13-d5ba-4827-91ec-3ed5176602b71
483440pregabalin 150 MG Oral CapsuleSCD613a7a13-d5ba-4827-91ec-3ed5176602b71
483446pregabalin 200 MG Oral CapsuleSCD613a7a13-d5ba-4827-91ec-3ed5176602b71
483448pregabalin 50 MG Oral CapsuleSCD613a7a13-d5ba-4827-91ec-3ed5176602b71
483450pregabalin 75 MG Oral CapsuleSCD613a7a13-d5ba-4827-91ec-3ed5176602b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58118-1467-85811814670830 CAPSULE in 1 BLISTER PACK (58118-1467-8) 30 capsule2026-02-13NoNoHistorical