FDA.reportPublic FDA data

Pregabalin

Product NDC
69238-1313
11-digit product format
692381313
Labeler code
69238
Product ID
69238-1313_670cafeb-c249-4782-838c-9537d3ede28b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209743
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1313-5Pregabalin500 in 1 BOTTLECAPSULE5008
69238-1313-9Pregabalin90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1313-9EA - Each69238-1313d7e5ce9b-6b59-480b-931f-e82890a45dbb12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1313PREGABALIN CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]7Current NDC, Legacy NDC, 2 package rows20240807_3d9d7123-5886-4b61-a7ea-471b213e77d9.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 CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483440pregabalin 150 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483446pregabalin 200 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
577127pregabalin 225 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483442pregabalin 25 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483444pregabalin 300 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483448pregabalin 50 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483450pregabalin 75 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483438pregabalin 100 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483440pregabalin 150 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483446pregabalin 200 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
577127pregabalin 225 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483442pregabalin 25 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483444pregabalin 300 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483448pregabalin 50 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483450pregabalin 75 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483438pregabalin 100 MG Oral CapsulePSNb817083c-b535-2269-e053-2a95a90af5b95
483438pregabalin 100 MG Oral CapsuleSCDb817083c-b535-2269-e053-2a95a90af5b95
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
69238-1313-569238131305500 CAPSULE in 1 BOTTLE (69238-1313-5) 500 capsule2019-07-19NoNoCurrent
69238-1313-96923813130990 CAPSULE in 1 BOTTLE (69238-1313-9) 90 capsule2019-07-190000-00-00NoNoCurrent