FDA.reportPublic FDA data

Pregabalin

Product NDC
50228-355
11-digit product format
502280355
Labeler code
50228
Product ID
50228-355_955253a7-d80a-44ef-83c4-74b33ee6a622
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, 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
50228-355-05Pregabalin500 in 1 BOTTLECAPSULE5009
50228-355-30Pregabalin30 in 1 BOTTLECAPSULE309
50228-355-90Pregabalin90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-355-90EA - Each50228-3552d8d2298-884f-40ef-83e9-32526438710112019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-355PREGABALIN CAPSULE [SCIEGEN PHARMACEUTICALS, INC]8Current NDC, Legacy NDC, 3 package rows20240629_33ef1a3b-554f-4a51-afdb-92a019e8c16c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483446pregabalin 200 MG Oral CapsulePSN2ceccc4d-97e2-4eb0-841f-23609187710c105
483446pregabalin 200 MG Oral CapsuleSCD2ceccc4d-97e2-4eb0-841f-23609187710c105
483446pregabalin 200 MG Oral CapsulePSNdf382975-73f1-4957-8959-177848f796f7104
483446pregabalin 200 MG Oral CapsuleSCDdf382975-73f1-4957-8959-177848f796f7104
483446pregabalin 200 MG Oral CapsulePSNb977269a-7d62-44a2-bd0d-11c54b872836103
483446pregabalin 200 MG Oral CapsuleSCDb977269a-7d62-44a2-bd0d-11c54b872836103
483438pregabalin 100 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483446pregabalin 200 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
577127pregabalin 225 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483442pregabalin 25 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483444pregabalin 300 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483438pregabalin 100 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483446pregabalin 200 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
577127pregabalin 225 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483442pregabalin 25 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483444pregabalin 300 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483438pregabalin 100 MG Oral CapsulePSN33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483440pregabalin 150 MG Oral CapsulePSN33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483446pregabalin 200 MG Oral CapsulePSN33ef1a3b-554f-4a51-afdb-92a019e8c16c9
577127pregabalin 225 MG Oral CapsulePSN33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483442pregabalin 25 MG Oral CapsulePSN33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483444pregabalin 300 MG Oral CapsulePSN33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483448pregabalin 50 MG Oral CapsulePSN33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483450pregabalin 75 MG Oral CapsulePSN33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483438pregabalin 100 MG Oral CapsuleSCD33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483440pregabalin 150 MG Oral CapsuleSCD33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483446pregabalin 200 MG Oral CapsuleSCD33ef1a3b-554f-4a51-afdb-92a019e8c16c9
577127pregabalin 225 MG Oral CapsuleSCD33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483442pregabalin 25 MG Oral CapsuleSCD33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483444pregabalin 300 MG Oral CapsuleSCD33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483448pregabalin 50 MG Oral CapsuleSCD33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483450pregabalin 75 MG Oral CapsuleSCD33ef1a3b-554f-4a51-afdb-92a019e8c16c9
483446pregabalin 200 MG Oral CapsulePSN8ac0689e-47a3-44d7-bf98-a919c302726d7
483446pregabalin 200 MG Oral CapsuleSCD8ac0689e-47a3-44d7-bf98-a919c302726d7
483446pregabalin 200 MG Oral CapsulePSN59432752-c8d8-4396-95dd-0e04c55bc82b3
483446pregabalin 200 MG Oral CapsuleSCD59432752-c8d8-4396-95dd-0e04c55bc82b3
483438pregabalin 100 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483438pregabalin 100 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483440pregabalin 150 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483440pregabalin 150 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483446pregabalin 200 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483446pregabalin 200 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483446pregabalin 200 MG Oral CapsulePSNf8ae62be-3a68-be6b-e053-6394a90ab6272
577127pregabalin 225 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
577127pregabalin 225 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483442pregabalin 25 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483444pregabalin 300 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483444pregabalin 300 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483448pregabalin 50 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483448pregabalin 50 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483450pregabalin 75 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483450pregabalin 75 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483438pregabalin 100 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483438pregabalin 100 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483440pregabalin 150 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483440pregabalin 150 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483446pregabalin 200 MG Oral CapsuleSCDf8ae62be-3a68-be6b-e053-6394a90ab6272
483446pregabalin 200 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483446pregabalin 200 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
577127pregabalin 225 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
577127pregabalin 225 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483442pregabalin 25 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483444pregabalin 300 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483444pregabalin 300 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483450pregabalin 75 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483450pregabalin 75 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483446pregabalin 200 MG Oral CapsulePSN27d02970-5f8b-4f4f-b89e-e42cc78ddaa31
483446pregabalin 200 MG Oral CapsuleSCD27d02970-5f8b-4f4f-b89e-e42cc78ddaa31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-355-0550228035505500 CAPSULE in 1 BOTTLE (50228-355-05) 500 capsule2019-07-190000-00-00NoNoCurrent
50228-355-305022803553030 CAPSULE in 1 BOTTLE (50228-355-30) 30 capsule2019-07-190000-00-00NoNoCurrent
50228-355-905022803559090 CAPSULE in 1 BOTTLE (50228-355-90) 90 capsule2019-07-190000-00-00NoNoCurrent