FDA.reportPublic FDA data

Pregabalin

Product NDC
50228-353
11-digit product format
502280353
Labeler code
50228
Product ID
50228-353_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
100 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
PREGABALIN100 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
50228-353-10Pregabalin1000 in 1 BOTTLECAPSULE10009
50228-353-30Pregabalin30 in 1 BOTTLECAPSULE309
50228-353-90Pregabalin90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-353-90EA - Each50228-353e6bebcd7-6e81-4051-a7a8-0912978a0c8412019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-353PREGABALIN 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
483438pregabalin 100 MG Oral CapsulePSNfd568ede-dac7-4910-bb18-65fb00f2636e105
483438pregabalin 100 MG Oral CapsuleSCDfd568ede-dac7-4910-bb18-65fb00f2636e105
483438pregabalin 100 MG Oral CapsulePSN29a869b8-0d9f-4e3f-820a-061aa42ee482103
483438pregabalin 100 MG Oral CapsulePSNc60f6b1e-7a24-41b2-8435-e20583a732c6103
483438pregabalin 100 MG Oral CapsuleSCD29a869b8-0d9f-4e3f-820a-061aa42ee482103
483438pregabalin 100 MG Oral CapsuleSCDc60f6b1e-7a24-41b2-8435-e20583a732c6103
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
483438pregabalin 100 MG Oral CapsulePSNceedde96-fdaf-4708-9ca1-e48e052cde757
483438pregabalin 100 MG Oral CapsuleSCDceedde96-fdaf-4708-9ca1-e48e052cde757
483438pregabalin 100 MG Oral CapsulePSN920c57e0-ddfe-4750-b353-5f96b65443cf4
483438pregabalin 100 MG Oral CapsulePSNf5d9b625-783c-bd78-e053-2995a90a37d24
483438pregabalin 100 MG Oral CapsuleSCDf5d9b625-783c-bd78-e053-2995a90a37d24
483438pregabalin 100 MG Oral CapsuleSCD920c57e0-ddfe-4750-b353-5f96b65443cf4
483438pregabalin 100 MG Oral CapsulePSNfc5dd378-950f-949b-e053-6394a90a3ca22
483438pregabalin 100 MG Oral CapsulePSNb60039c6-f99f-896e-e053-2995a90aa19d2
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
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 CapsulePSN1ef735e8-467e-ed0d-e063-6294a90a210e2
483450pregabalin 75 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483438pregabalin 100 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483438pregabalin 100 MG Oral CapsuleSCDfc5dd378-950f-949b-e053-6394a90a3ca22
483438pregabalin 100 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483438pregabalin 100 MG Oral CapsuleSCDb60039c6-f99f-896e-e053-2995a90aa19d2
483440pregabalin 150 MG Oral CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483440pregabalin 150 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
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 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 CapsuleSCD1ef735e8-467e-ed0d-e063-6294a90a210e2
483450pregabalin 75 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483438pregabalin 100 MG Oral CapsulePSN8f234d4b-4989-2f0f-e053-2a95a90ae16d1
483438pregabalin 100 MG Oral CapsulePSN8f22f1e4-15ef-734a-e053-2995a90a33911
483438pregabalin 100 MG Oral CapsulePSN3c6daa12-5284-d9f1-e063-6294a90ae0601
483438pregabalin 100 MG Oral CapsulePSN8f21ab56-1690-70fa-e053-2995a90a25021
483438pregabalin 100 MG Oral CapsulePSNe72c20f2-9eff-6d2b-e053-2995a90af90f1
483438pregabalin 100 MG Oral CapsuleSCD3c6daa12-5284-d9f1-e063-6294a90ae0601
483438pregabalin 100 MG Oral CapsuleSCDe72c20f2-9eff-6d2b-e053-2995a90af90f1
483438pregabalin 100 MG Oral CapsuleSCD8f21ab56-1690-70fa-e053-2995a90a25021
483438pregabalin 100 MG Oral CapsuleSCD8f22f1e4-15ef-734a-e053-2995a90a33911
483438pregabalin 100 MG Oral CapsuleSCD8f234d4b-4989-2f0f-e053-2a95a90ae16d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-353-10502280353101000 CAPSULE in 1 BOTTLE (50228-353-10) 1000 capsule2019-07-190000-00-00NoNoCurrent
50228-353-305022803533030 CAPSULE in 1 BOTTLE (50228-353-30) 30 capsule2019-07-190000-00-00NoNoCurrent
50228-353-905022803539090 CAPSULE in 1 BOTTLE (50228-353-90) 90 capsule2019-07-190000-00-00NoNoCurrent