Pregabalin

Product NDC
71335-1788
11-digit product format
713351788
Labeler code
71335
Product ID
71335-1788_0fc8c9a3-79bf-4ff9-84bd-3c47d43b953b
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
75 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
PREGABALIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483450

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
71335-1788-1Pregabalin30 in 1 BOTTLECAPSULE30104
71335-1788-2Pregabalin60 in 1 BOTTLECAPSULE60104
71335-1788-3Pregabalin90 in 1 BOTTLECAPSULE90104
71335-1788-4Pregabalin120 in 1 BOTTLECAPSULE120104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1788-1EA - Each71335-178804b5e00f-dea0-4927-9513-b6dae7fad27112023-12-05
71335-1788-2EA - Each71335-1788027a6afe-e6ce-4490-880a-503bee0c658312022-08-04
71335-1788-3EA - Each71335-17884a19c0eb-e82c-45f9-90df-b284e56cc65e12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1788PREGABALIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 4 package rows20250522_c72b0bed-b7b4-4ae1-914e-756d76b66ed9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSNc72b0bed-b7b4-4ae1-914e-756d76b66ed9104
483450pregabalin 75 MG Oral CapsuleSCDc72b0bed-b7b4-4ae1-914e-756d76b66ed9104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1788-17133517880130 CAPSULE in 1 BOTTLE (71335-1788-1) 30 capsule2021-03-040000-00-00NoNoCurrent
71335-1788-27133517880260 CAPSULE in 1 BOTTLE (71335-1788-2) 60 capsule2021-03-030000-00-00NoNoCurrent
71335-1788-37133517880390 CAPSULE in 1 BOTTLE (71335-1788-3) 90 capsule2021-03-030000-00-00NoNoCurrent
71335-1788-471335178804120 CAPSULE in 1 BOTTLE (71335-1788-4) 120 capsule2022-01-060000-00-00NoNoCurrent