Pregabalin

Product NDC
50436-0326
11-digit product format
504360326
Labeler code
50436
Product ID
50436-0326_a343071b-f8dc-415e-9d89-a577062249e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA208677
Marketing category
ANDA
Marketing start
2021-08-24
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
75 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0326-1Pregabalin30 in 1 BOTTLECAPSULE303
50436-0326-2Pregabalin60 in 1 BOTTLECAPSULE603
50436-0326-3Pregabalin90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0326-1EA - Each50436-0326529bbf73-3558-4081-9880-4b152bd66c6f12021-11-09
50436-0326-2EA - Each50436-0326ae904ecd-f411-48fd-8301-befe08e7808f12021-11-09
50436-0326-3EA - Each50436-0326ea0d6e92-7520-42a1-ae32-050da658dba512021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0326PREGABALIN CAPSULE [UNIT DOSE SERVICES]3Legacy NDC, 3 package rows20211106_10e1c465-5cc4-403a-9c70-41dafc354dba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN10e1c465-5cc4-403a-9c70-41dafc354dba3
483450pregabalin 75 MG Oral CapsulePSN10e1c465-5cc4-403a-9c70-41dafc354dba3
483448pregabalin 50 MG Oral CapsuleSCD10e1c465-5cc4-403a-9c70-41dafc354dba3
483450pregabalin 75 MG Oral CapsuleSCD10e1c465-5cc4-403a-9c70-41dafc354dba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-0326-15043603260130 CAPSULE in 1 BOTTLE (50436-0326-1) 30 capsule2021-11-010000-00-00NoNoCurrent
50436-0326-25043603260260 CAPSULE in 1 BOTTLE (50436-0326-2) 60 capsule2021-11-010000-00-00NoNoCurrent
50436-0326-35043603260390 CAPSULE in 1 BOTTLE (50436-0326-3) 90 capsule2021-11-010000-00-00NoNoCurrent