FDA.reportPublic FDA data

PREGABALIN

Product NDC
64980-416
11-digit product format
649800416
Labeler code
64980
Product ID
64980-416_ed8357e8-6f9d-4b09-b3f0-48417fe7f481
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA210432
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
225 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
PREGABALIN225 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
64980-416-01PREGABALIN10 in 1 BLISTER PACKCAPSULE1014
64980-416-01PREGABALIN10 in 1 CARTONCAPSULE1014
64980-416-09PREGABALIN90 in 1 BOTTLECAPSULE9014
64980-416-10PREGABALIN1000 in 1 BOTTLECAPSULE100014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-416PREGABALIN CAPSULE [RISING PHARMA HOLDINGS, INC.]12Current NDC, Legacy NDC, 4 package rows20240316_dbebfa61-0685-41b4-8364-00b8d8b73714.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577127pregabalin 225 MG Oral CapsulePSN3ce4dfdf-e32f-40e8-9a13-e45d51539e08106
577127pregabalin 225 MG Oral CapsuleSCD3ce4dfdf-e32f-40e8-9a13-e45d51539e08106
483438pregabalin 100 MG Oral CapsulePSNdbebfa61-0685-41b4-8364-00b8d8b7371414
483440pregabalin 150 MG Oral CapsulePSNdbebfa61-0685-41b4-8364-00b8d8b7371414
483446pregabalin 200 MG Oral CapsulePSNdbebfa61-0685-41b4-8364-00b8d8b7371414
577127pregabalin 225 MG Oral CapsulePSNdbebfa61-0685-41b4-8364-00b8d8b7371414
483442pregabalin 25 MG Oral CapsulePSNdbebfa61-0685-41b4-8364-00b8d8b7371414
483444pregabalin 300 MG Oral CapsulePSNdbebfa61-0685-41b4-8364-00b8d8b7371414
483448pregabalin 50 MG Oral CapsulePSNdbebfa61-0685-41b4-8364-00b8d8b7371414
483450pregabalin 75 MG Oral CapsulePSNdbebfa61-0685-41b4-8364-00b8d8b7371414
483438pregabalin 100 MG Oral CapsuleSCDdbebfa61-0685-41b4-8364-00b8d8b7371414
483440pregabalin 150 MG Oral CapsuleSCDdbebfa61-0685-41b4-8364-00b8d8b7371414
483446pregabalin 200 MG Oral CapsuleSCDdbebfa61-0685-41b4-8364-00b8d8b7371414
577127pregabalin 225 MG Oral CapsuleSCDdbebfa61-0685-41b4-8364-00b8d8b7371414
483442pregabalin 25 MG Oral CapsuleSCDdbebfa61-0685-41b4-8364-00b8d8b7371414
483444pregabalin 300 MG Oral CapsuleSCDdbebfa61-0685-41b4-8364-00b8d8b7371414
483448pregabalin 50 MG Oral CapsuleSCDdbebfa61-0685-41b4-8364-00b8d8b7371414
483450pregabalin 75 MG Oral CapsuleSCDdbebfa61-0685-41b4-8364-00b8d8b7371414
483438pregabalin 100 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483440pregabalin 150 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483446pregabalin 200 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
577127pregabalin 225 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483442pregabalin 25 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483444pregabalin 300 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483448pregabalin 50 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483450pregabalin 75 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483438pregabalin 100 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483440pregabalin 150 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483446pregabalin 200 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
577127pregabalin 225 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483442pregabalin 25 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483444pregabalin 300 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483448pregabalin 50 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483450pregabalin 75 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483438pregabalin 100 MG Oral CapsulePSN69b8a843-a3a8-4d76-8418-f482886250301
483440pregabalin 150 MG Oral CapsulePSN69b8a843-a3a8-4d76-8418-f482886250301
483446pregabalin 200 MG Oral CapsulePSN69b8a843-a3a8-4d76-8418-f482886250301
577127pregabalin 225 MG Oral CapsulePSN1a8f13f6-0f4c-4194-ba37-b2d1a8fc49931
577127pregabalin 225 MG Oral CapsulePSN69b8a843-a3a8-4d76-8418-f482886250301
483442pregabalin 25 MG Oral CapsulePSN69b8a843-a3a8-4d76-8418-f482886250301
483444pregabalin 300 MG Oral CapsulePSN69b8a843-a3a8-4d76-8418-f482886250301
483448pregabalin 50 MG Oral CapsulePSN69b8a843-a3a8-4d76-8418-f482886250301
483450pregabalin 75 MG Oral CapsulePSN69b8a843-a3a8-4d76-8418-f482886250301
483438pregabalin 100 MG Oral CapsuleSCD69b8a843-a3a8-4d76-8418-f482886250301
483440pregabalin 150 MG Oral CapsuleSCD69b8a843-a3a8-4d76-8418-f482886250301
483446pregabalin 200 MG Oral CapsuleSCD69b8a843-a3a8-4d76-8418-f482886250301
577127pregabalin 225 MG Oral CapsuleSCD1a8f13f6-0f4c-4194-ba37-b2d1a8fc49931
577127pregabalin 225 MG Oral CapsuleSCD69b8a843-a3a8-4d76-8418-f482886250301
483442pregabalin 25 MG Oral CapsuleSCD69b8a843-a3a8-4d76-8418-f482886250301
483444pregabalin 300 MG Oral CapsuleSCD69b8a843-a3a8-4d76-8418-f482886250301
483448pregabalin 50 MG Oral CapsuleSCD69b8a843-a3a8-4d76-8418-f482886250301
483450pregabalin 75 MG Oral CapsuleSCD69b8a843-a3a8-4d76-8418-f482886250301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-416-016498004160110 BLISTER PACK in 1 CARTON (64980-416-01) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2019-07-190000-00-00NoNoCurrent
64980-416-096498004160990 CAPSULE in 1 BOTTLE (64980-416-09) 90 capsule2019-07-190000-00-00NoNoCurrent
64980-416-10649800416101000 CAPSULE in 1 BOTTLE (64980-416-10) 1000 capsule2019-07-190000-00-00NoNoCurrent