FDA.reportPublic FDA data

Pregabalin

Product NDC
50228-351
11-digit product format
502280351
Labeler code
50228
Product ID
50228-351_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
50 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
PREGABALIN50 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
50228-351-10Pregabalin1000 in 1 BOTTLECAPSULE10009
50228-351-30Pregabalin30 in 1 BOTTLECAPSULE309
50228-351-90Pregabalin90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-351-90EA - Each50228-3515d07be8a-0077-4f50-98ea-da0464705e7912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-351PREGABALIN 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
483448pregabalin 50 MG Oral CapsulePSN36085f4e-91ae-458c-b0a0-81363112df01103
483448pregabalin 50 MG Oral CapsuleSCD36085f4e-91ae-458c-b0a0-81363112df01103
483448pregabalin 50 MG Oral CapsulePSN247aedca-ae27-44c6-b32c-c95d2645456623
483448pregabalin 50 MG Oral CapsuleSCD247aedca-ae27-44c6-b32c-c95d2645456623
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 CapsulePSNaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483448pregabalin 50 MG Oral CapsulePSNaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483448pregabalin 50 MG Oral CapsulePSN3dbfd868-8408-4514-ba1c-04a5d095c16a7
483440pregabalin 150 MG Oral CapsuleSCDaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483448pregabalin 50 MG Oral CapsuleSCD3dbfd868-8408-4514-ba1c-04a5d095c16a7
483448pregabalin 50 MG Oral CapsuleSCDaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483448pregabalin 50 MG Oral CapsulePSN9235cd08-7a25-4b81-e053-2995a90a539c6
483448pregabalin 50 MG Oral CapsuleSCD9235cd08-7a25-4b81-e053-2995a90a539c6
483448pregabalin 50 MG Oral CapsulePSNb534c542-021c-98e9-e053-2a95a90a22fa3
483448pregabalin 50 MG Oral CapsulePSN8efb9652-86b9-4cb5-e053-2995a90adac03
483448pregabalin 50 MG Oral CapsuleSCDb534c542-021c-98e9-e053-2a95a90a22fa3
483448pregabalin 50 MG Oral CapsuleSCD8efb9652-86b9-4cb5-e053-2995a90adac03
483438pregabalin 100 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483438pregabalin 100 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483446pregabalin 200 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483446pregabalin 200 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
577127pregabalin 225 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
577127pregabalin 225 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483442pregabalin 25 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsulePSNf98c5df7-9b85-eacc-e053-6294a90a88ec2
483444pregabalin 300 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483444pregabalin 300 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483448pregabalin 50 MG Oral CapsulePSN89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b2
483448pregabalin 50 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483448pregabalin 50 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsulePSNf98c5df7-9b85-eacc-e053-6294a90a88ec2
483448pregabalin 50 MG Oral CapsulePSNb9f96190-75f0-07a0-e053-2995a90ab3d92
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 CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
577127pregabalin 225 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsuleSCDf98c5df7-9b85-eacc-e053-6294a90a88ec2
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 CapsuleSCD89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b2
483448pregabalin 50 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsuleSCDb9f96190-75f0-07a0-e053-2995a90ab3d92
483448pregabalin 50 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483448pregabalin 50 MG Oral CapsuleSCDf98c5df7-9b85-eacc-e053-6294a90a88ec2
483450pregabalin 75 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483450pregabalin 75 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483448pregabalin 50 MG Oral CapsulePSN8efb49b4-27e9-a1a1-e053-2a95a90ae5b81
483448pregabalin 50 MG Oral CapsulePSN8efaf0a6-955a-f74d-e053-2a95a90ab3391
483448pregabalin 50 MG Oral CapsuleSCD8efb49b4-27e9-a1a1-e053-2a95a90ae5b81
483448pregabalin 50 MG Oral CapsuleSCD8efaf0a6-955a-f74d-e053-2a95a90ab3391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-351-10502280351101000 CAPSULE in 1 BOTTLE (50228-351-10) 1000 capsule2019-07-190000-00-00NoNoCurrent
50228-351-305022803513030 CAPSULE in 1 BOTTLE (50228-351-30) 30 capsule2019-07-190000-00-00NoNoCurrent
50228-351-905022803519090 CAPSULE in 1 BOTTLE (50228-351-90) 90 capsule2019-07-190000-00-00NoNoCurrent