FDA.reportPublic FDA data

Pregabalin

Product NDC
50228-354
11-digit product format
502280354
Labeler code
50228
Product ID
50228-354_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
150 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
PREGABALIN150 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
50228-354-10Pregabalin1000 in 1 BOTTLECAPSULE10009
50228-354-30Pregabalin30 in 1 BOTTLECAPSULE309
50228-354-90Pregabalin90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-354-90EA - Each50228-35439033b2c-cd59-4300-9580-4c78e312bd7012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-354PREGABALIN 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
483440pregabalin 150 MG Oral CapsulePSN8a7acea4-108d-40d2-a2a7-36088be97248105
483440pregabalin 150 MG Oral CapsuleSCD8a7acea4-108d-40d2-a2a7-36088be97248105
483440pregabalin 150 MG Oral CapsulePSNdbf3647a-5ab1-450e-be5f-69b844185572104
483440pregabalin 150 MG Oral CapsuleSCDdbf3647a-5ab1-450e-be5f-69b844185572104
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
483440pregabalin 150 MG Oral CapsulePSN25345672-1368-4e3a-95b2-ca45fe1202947
483440pregabalin 150 MG Oral CapsulePSNaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483448pregabalin 50 MG Oral CapsulePSNaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483440pregabalin 150 MG Oral CapsuleSCD25345672-1368-4e3a-95b2-ca45fe1202947
483440pregabalin 150 MG Oral CapsuleSCDaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483448pregabalin 50 MG Oral CapsuleSCDaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483440pregabalin 150 MG Oral CapsulePSN923745e9-17a2-a5f7-e053-2a95a90aed383
483440pregabalin 150 MG Oral CapsuleSCD923745e9-17a2-a5f7-e053-2a95a90aed383
483438pregabalin 100 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483438pregabalin 100 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483440pregabalin 150 MG Oral CapsulePSNa0f2b8af-0a04-4db0-adb3-d9d9369223d92
483440pregabalin 150 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsulePSNb762120e-583a-2d98-e053-2995a90a687d2
483440pregabalin 150 MG Oral CapsulePSN1a15cd11-0db9-2bc8-e063-6394a90a11fb2
483446pregabalin 200 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483446pregabalin 200 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
577127pregabalin 225 MG Oral CapsulePSN1a15cd11-0db9-2bc8-e063-6394a90a11fb2
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 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
483440pregabalin 150 MG Oral CapsuleSCDb762120e-583a-2d98-e053-2995a90a687d2
483440pregabalin 150 MG Oral CapsuleSCD1a15cd11-0db9-2bc8-e063-6394a90a11fb2
483440pregabalin 150 MG Oral CapsuleSCDa0f2b8af-0a04-4db0-adb3-d9d9369223d92
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 CapsuleSCD1a15cd11-0db9-2bc8-e063-6394a90a11fb2
577127pregabalin 225 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483442pregabalin 25 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483442pregabalin 25 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483444pregabalin 300 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483444pregabalin 300 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483448pregabalin 50 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483450pregabalin 75 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483450pregabalin 75 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsulePSN9053ff4e-cc47-4fa8-990a-4b0d539a480a1
483440pregabalin 150 MG Oral CapsulePSN8efaa78b-a961-4b04-e053-2a95a90aae341
483440pregabalin 150 MG Oral CapsulePSN8efa6436-6430-4afe-e053-2a95a90acb1c1
483440pregabalin 150 MG Oral CapsulePSN8efa32d7-37cc-920a-e053-2995a90a37981
483440pregabalin 150 MG Oral CapsuleSCD9053ff4e-cc47-4fa8-990a-4b0d539a480a1
483440pregabalin 150 MG Oral CapsuleSCD8efaa78b-a961-4b04-e053-2a95a90aae341
483440pregabalin 150 MG Oral CapsuleSCD8efa6436-6430-4afe-e053-2a95a90acb1c1
483440pregabalin 150 MG Oral CapsuleSCD8efa32d7-37cc-920a-e053-2995a90a37981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-354-10502280354101000 CAPSULE in 1 BOTTLE (50228-354-10) 1000 capsule2019-07-190000-00-00NoNoCurrent
50228-354-305022803543030 CAPSULE in 1 BOTTLE (50228-354-30) 30 capsule2019-07-190000-00-00NoNoCurrent
50228-354-905022803549090 CAPSULE in 1 BOTTLE (50228-354-90) 90 capsule2019-07-190000-00-00NoNoCurrent