FDA.reportPublic FDA data

Pregabalin

Product NDC
31722-611
11-digit product format
317220611
Labeler code
31722
Product ID
31722-611_3ff00691-3fde-ae93-e063-6294a90adcc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA206912
Marketing category
ANDA
Marketing start
2019-10-08
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-611-05Pregabalin500 in 1 BOTTLECAPSULE5003
31722-611-31Pregabalin10 in 1 CARTONCAPSULE103
31722-611-31Pregabalin10 in 1 BLISTER PACKCAPSULE103
31722-611-32Pregabalin10 in 1 CARTONCAPSULE103
31722-611-32Pregabalin7 in 1 BLISTER PACKCAPSULE73
31722-611-60Pregabalin60 in 1 BOTTLECAPSULE603
31722-611-90Pregabalin90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-611-05EA - Each31722-611fecc6767-66e2-4ad4-bba4-9eabc35c761312022-06-06
31722-611-90EA - Each31722-61190f83427-8da5-4b01-b7e8-e63f6c5843dc12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-611PREGABALIN (PREGABALIN) CAPSULE [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 7 package rows20240713_241c4b7e-f719-4828-8639-ea613b8a6583.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN48798c13-3ef4-4e7f-9f73-92dccac0af14104
483448pregabalin 50 MG Oral CapsuleSCD48798c13-3ef4-4e7f-9f73-92dccac0af14104
483448pregabalin 50 MG Oral CapsulePSNc8acdbcf-3076-63b2-e053-2a95a90aa3c47
483448pregabalin 50 MG Oral CapsuleSCDc8acdbcf-3076-63b2-e053-2a95a90aa3c47
483438pregabalin 100 MG Oral CapsulePSN241c4b7e-f719-4828-8639-ea613b8a65833
483440pregabalin 150 MG Oral CapsulePSN241c4b7e-f719-4828-8639-ea613b8a65833
483446pregabalin 200 MG Oral CapsulePSN241c4b7e-f719-4828-8639-ea613b8a65833
577127pregabalin 225 MG Oral CapsulePSN241c4b7e-f719-4828-8639-ea613b8a65833
483442pregabalin 25 MG Oral CapsulePSN241c4b7e-f719-4828-8639-ea613b8a65833
483444pregabalin 300 MG Oral CapsulePSN241c4b7e-f719-4828-8639-ea613b8a65833
483448pregabalin 50 MG Oral CapsulePSN7f29991e-3bf5-4e48-8fa3-6d4e932ed6de3
483448pregabalin 50 MG Oral CapsulePSN241c4b7e-f719-4828-8639-ea613b8a65833
483450pregabalin 75 MG Oral CapsulePSN241c4b7e-f719-4828-8639-ea613b8a65833
483438pregabalin 100 MG Oral CapsuleSCD241c4b7e-f719-4828-8639-ea613b8a65833
483440pregabalin 150 MG Oral CapsuleSCD241c4b7e-f719-4828-8639-ea613b8a65833
483446pregabalin 200 MG Oral CapsuleSCD241c4b7e-f719-4828-8639-ea613b8a65833
577127pregabalin 225 MG Oral CapsuleSCD241c4b7e-f719-4828-8639-ea613b8a65833
483442pregabalin 25 MG Oral CapsuleSCD241c4b7e-f719-4828-8639-ea613b8a65833
483444pregabalin 300 MG Oral CapsuleSCD241c4b7e-f719-4828-8639-ea613b8a65833
483448pregabalin 50 MG Oral CapsuleSCD241c4b7e-f719-4828-8639-ea613b8a65833
483448pregabalin 50 MG Oral CapsuleSCD7f29991e-3bf5-4e48-8fa3-6d4e932ed6de3
483450pregabalin 75 MG Oral CapsuleSCD241c4b7e-f719-4828-8639-ea613b8a65833
483448pregabalin 50 MG Oral CapsulePSN2c62e63a-fe81-a463-e063-6394a90a65ee1
483448pregabalin 50 MG Oral CapsulePSNc60752f8-20d5-4333-bf33-a656eab01d6b1
483448pregabalin 50 MG Oral CapsulePSN2b87989d-6411-4996-8f05-05806ab805251
483448pregabalin 50 MG Oral CapsuleSCD2c62e63a-fe81-a463-e063-6394a90a65ee1
483448pregabalin 50 MG Oral CapsuleSCDc60752f8-20d5-4333-bf33-a656eab01d6b1
483448pregabalin 50 MG Oral CapsuleSCD2b87989d-6411-4996-8f05-05806ab805251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-611-0531722061105500 CAPSULE in 1 BOTTLE (31722-611-05) 500 capsule2019-10-080000-00-00NoNoCurrent
31722-611-313172206113110 BLISTER PACK in 1 CARTON (31722-611-31) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2019-10-080000-00-00NoNoCurrent
31722-611-323172206113210 BLISTER PACK in 1 CARTON (31722-611-32) / 7 CAPSULE in 1 BLISTER PACK10 blister pack2019-10-080000-00-00NoNoCurrent
31722-611-603172206116060 CAPSULE in 1 BOTTLE (31722-611-60) 60 capsule2019-10-080000-00-00NoNoCurrent
31722-611-903172206119090 CAPSULE in 1 BOTTLE (31722-611-90) 90 capsule2019-10-080000-00-00NoNoCurrent