FDA.reportPublic FDA data

Pregabalin

Product NDC
31722-617
11-digit product format
317220617
Labeler code
31722
Product ID
31722-617_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
300 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
PREGABALIN300 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
31722-617-05Pregabalin500 in 1 BOTTLECAPSULE5003
31722-617-31Pregabalin10 in 1 BLISTER PACKCAPSULE103
31722-617-31Pregabalin10 in 1 CARTONCAPSULE103
31722-617-32Pregabalin10 in 1 BLISTER PACKCAPSULE103
31722-617-32Pregabalin10 in 1 CARTONCAPSULE103
31722-617-60Pregabalin60 in 1 BOTTLECAPSULE603
31722-617-90Pregabalin90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-617-05EA - Each31722-617f270092d-0c3b-4c2d-8065-fea83cafe99e12022-06-06
31722-617-90EA - Each31722-617673d57a1-f619-4d26-bc4d-18fe6d93ec9712020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-617PREGABALIN (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
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 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
483450pregabalin 75 MG Oral CapsuleSCD241c4b7e-f719-4828-8639-ea613b8a65833

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-617-0531722061705500 CAPSULE in 1 BOTTLE (31722-617-05) 500 capsule2019-10-080000-00-00NoNoCurrent
31722-617-313172206173110 BLISTER PACK in 1 CARTON (31722-617-31) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2019-10-080000-00-00NoNoCurrent
31722-617-323172206173210 BLISTER PACK in 1 CARTON (31722-617-32) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2019-10-080000-00-00NoNoCurrent
31722-617-603172206176060 CAPSULE in 1 BOTTLE (31722-617-60) 60 capsule2019-10-080000-00-00NoNoCurrent
31722-617-903172206179090 CAPSULE in 1 BOTTLE (31722-617-90) 90 capsule2019-10-080000-00-00NoNoCurrent