PREGABALIN

Product NDC
72189-033
11-digit product format
721890033
Labeler code
72189
Product ID
72189-033_2be8eb66-533f-0815-e063-6294a90a115d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209743
Marketing category
ANDA
Marketing start
2019-09-05
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, 483442, 483444, 483446, 577127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-033-602023-01-30C16284748780-1f386c649-d49f-0266-e053-dadaa90a7c1aPREGABALIN
72189-033-902023-01-30C16284748780-1f386c64a-3c7a-0266-e053-dadaa90a7c1aPREGABALIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-033-30PREGABALIN30 in 1 BOTTLECAPSULE3013
72189-033-60PREGABALIN60 in 1 BOTTLECAPSULE601
72189-033-90PREGABALIN90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-033PREGABALIN CAPSULE [DIRECT_RX]13Current NDC, Legacy NDC, 1 package rows20250119_91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d.zip
72189-033PREGABALIN CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190906_91cf34b3-d546-3110-e053-2995a90a5788.zip
72189-033PREGABALIN CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190906_91cf4a51-18aa-06a6-e053-2995a90a93bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 CapsulePSN91cf34b3-d546-3110-e053-2995a90a57881
483438pregabalin 100 MG Oral CapsulePSN91cf4a51-18aa-06a6-e053-2995a90a93bd1
483438pregabalin 100 MG Oral CapsuleSCD91cf34b3-d546-3110-e053-2995a90a57881
483438pregabalin 100 MG Oral CapsuleSCD91cf4a51-18aa-06a6-e053-2995a90a93bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-033-307218900333030 CAPSULE in 1 BOTTLE (72189-033-30) 30 capsule2019-09-050000-00-00NoNoCurrent
72189-033-607218900336060 CAPSULE in 1 BOTTLE (72189-033-60) 60 capsule2019-09-050000-00-00NoNoCurrent
72189-033-907218900339090 CAPSULE in 1 BOTTLE (72189-033-90) 90 capsule2019-09-050000-00-00NoNoCurrent