FDA.reportPublic FDA data

Pregabalin

Product NDC
50228-357
11-digit product format
502280357
Labeler code
50228
Product ID
50228-357_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
300 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
PREGABALIN300 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-357-05Pregabalin500 in 1 BOTTLECAPSULE5009
50228-357-30Pregabalin30 in 1 BOTTLECAPSULE309
50228-357-90Pregabalin90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-357-90EA - Each50228-357d1a0b460-cdd2-4089-9b1f-f81df455ff8212019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-357PREGABALIN 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
483444pregabalin 300 MG Oral CapsulePSN59f94cd9-0fc9-4e55-8004-578971a1b42f106
483444pregabalin 300 MG Oral CapsuleSCD59f94cd9-0fc9-4e55-8004-578971a1b42f106
483444pregabalin 300 MG Oral CapsulePSN47cc53e6-e679-4a01-babc-af301dd756f7105
483444pregabalin 300 MG Oral CapsuleSCD47cc53e6-e679-4a01-babc-af301dd756f7105
483444pregabalin 300 MG Oral CapsulePSNfd01590e-5b90-4a77-ad5f-76adabf3c32e103
483444pregabalin 300 MG Oral CapsuleSCDfd01590e-5b90-4a77-ad5f-76adabf3c32e103
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
483444pregabalin 300 MG Oral CapsulePSNd2804923-a466-6dc6-e053-2a95a90a41825
483444pregabalin 300 MG Oral CapsulePSN8c3aedae-9745-4f63-ad64-a643f02454185
483444pregabalin 300 MG Oral CapsuleSCD8c3aedae-9745-4f63-ad64-a643f02454185
483444pregabalin 300 MG Oral CapsuleSCDd2804923-a466-6dc6-e053-2a95a90a41825
483438pregabalin 100 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483438pregabalin 100 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483440pregabalin 150 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483446pregabalin 200 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483446pregabalin 200 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
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 CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483444pregabalin 300 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
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 CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483446pregabalin 200 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483446pregabalin 200 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
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 CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483444pregabalin 300 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483448pregabalin 50 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483450pregabalin 75 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483450pregabalin 75 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483444pregabalin 300 MG Oral CapsulePSN124d7552-e48d-b160-e063-6294a90a196f1
483444pregabalin 300 MG Oral CapsuleSCD124d7552-e48d-b160-e063-6294a90a196f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-357-0550228035705500 CAPSULE in 1 BOTTLE (50228-357-05) 500 capsule2019-07-190000-00-00NoNoCurrent
50228-357-305022803573030 CAPSULE in 1 BOTTLE (50228-357-30) 30 capsule2019-07-190000-00-00NoNoCurrent
50228-357-905022803579090 CAPSULE in 1 BOTTLE (50228-357-90) 90 capsule2019-07-190000-00-00NoNoCurrent