FDA.reportPublic FDA data

Pregabalin

Product NDC
71335-1792
11-digit product format
713351792
Labeler code
71335
Product ID
71335-1792_ba13c055-39a8-45c2-9ecd-96fd8d1d235d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206912
Marketing category
ANDA
Marketing start
2019-10-08
Substance
PREGABALIN
Active strength
150 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
PREGABALIN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483440

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1792-1Pregabalin30 in 1 BOTTLECAPSULE30104
71335-1792-2Pregabalin60 in 1 BOTTLECAPSULE60104
71335-1792-3Pregabalin90 in 1 BOTTLECAPSULE90104
71335-1792-4Pregabalin180 in 1 BOTTLECAPSULE180104
71335-1792-5Pregabalin120 in 1 BOTTLECAPSULE120104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1792-1EA - Each71335-1792a255b73f-f39f-463b-b6bf-3440da88c0a812022-01-06
71335-1792-2EA - Each71335-1792da895551-ac44-45f1-9088-05f195c3cd6c12022-01-06
71335-1792-3EA - Each71335-1792656fd1f3-60d7-46b3-8ad7-8ccbe0f6830812022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1792PREGABALIN (PREGABALIN) CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 5 package rows20240824_616b37d6-93d5-44de-a993-bddf59eaee9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSN616b37d6-93d5-44de-a993-bddf59eaee9a104
483440pregabalin 150 MG Oral CapsuleSCD616b37d6-93d5-44de-a993-bddf59eaee9a104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1792-17133517920130 CAPSULE in 1 BOTTLE (71335-1792-1) 30 capsule2021-03-090000-00-00NoNoCurrent
71335-1792-27133517920260 CAPSULE in 1 BOTTLE (71335-1792-2) 60 capsule2021-03-050000-00-00NoNoCurrent
71335-1792-37133517920390 CAPSULE in 1 BOTTLE (71335-1792-3) 90 capsule2021-03-180000-00-00NoNoCurrent
71335-1792-471335179204180 CAPSULE in 1 BOTTLE (71335-1792-4) 180 capsule2021-06-150000-00-00NoNoCurrent
71335-1792-571335179205120 CAPSULE in 1 BOTTLE (71335-1792-5) 120 capsule2023-08-23NoNoCurrent