FDA.reportPublic FDA data

Pregabalin

Product NDC
50228-350
11-digit product format
502280350
Labeler code
50228
Product ID
50228-350_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
25 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
PREGABALIN25 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
50228-350-10Pregabalin1000 in 1 BOTTLECAPSULE10009
50228-350-30Pregabalin30 in 1 BOTTLECAPSULE309
50228-350-90Pregabalin90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-350-90EA - Each50228-3500e982d33-315f-45e7-b417-fe680a1ec33712019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-350PREGABALIN 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
483442pregabalin 25 MG Oral CapsulePSN025c3adb-5f6b-45f5-a4c6-cea8e57102e3105
483442pregabalin 25 MG Oral CapsuleSCD025c3adb-5f6b-45f5-a4c6-cea8e57102e3105
483442pregabalin 25 MG Oral CapsulePSN90b65884-4222-4011-b042-88b83e51c57a104
483442pregabalin 25 MG Oral CapsuleSCD90b65884-4222-4011-b042-88b83e51c57a104
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
483442pregabalin 25 MG Oral CapsulePSNce1419bc-c348-4407-b320-e0598d5a7b196
483442pregabalin 25 MG Oral CapsuleSCDce1419bc-c348-4407-b320-e0598d5a7b196
483442pregabalin 25 MG Oral CapsulePSN1e087436-0534-4de2-b310-a5cc0e46adbd4
483442pregabalin 25 MG Oral CapsuleSCD1e087436-0534-4de2-b310-a5cc0e46adbd4
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 CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483442pregabalin 25 MG Oral CapsulePSNf98c5df7-9b85-eacc-e053-6294a90a88ec2
483444pregabalin 300 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483444pregabalin 300 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsulePSNf98c5df7-9b85-eacc-e053-6294a90a88ec2
483448pregabalin 50 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483448pregabalin 50 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483450pregabalin 75 MG Oral CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483450pregabalin 75 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483438pregabalin 100 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483438pregabalin 100 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
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 CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483442pregabalin 25 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsuleSCDf98c5df7-9b85-eacc-e053-6294a90a88ec2
483444pregabalin 300 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483444pregabalin 300 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483448pregabalin 50 MG Oral CapsuleSCDf98c5df7-9b85-eacc-e053-6294a90a88ec2
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
483442pregabalin 25 MG Oral CapsulePSN38e80423-0194-4064-9447-abfd29fce1da1
483442pregabalin 25 MG Oral CapsuleSCD38e80423-0194-4064-9447-abfd29fce1da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-350-10502280350101000 CAPSULE in 1 BOTTLE (50228-350-10) 1000 capsule2019-07-190000-00-00NoNoCurrent
50228-350-305022803503030 CAPSULE in 1 BOTTLE (50228-350-30) 30 capsule2019-07-190000-00-00NoNoCurrent
50228-350-905022803509090 CAPSULE in 1 BOTTLE (50228-350-90) 90 capsule2019-07-190000-00-00NoNoCurrent