FDA.reportPublic FDA data

Pregabalin

Product NDC
71335-1822
11-digit product format
713351822
Labeler code
71335
Product ID
71335-1822_99a3d5ea-2eb0-4298-b112-93d0e3233eb7
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
200 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
PREGABALIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483446

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
71335-1822-1Pregabalin30 in 1 BOTTLECAPSULE30104
71335-1822-2Pregabalin60 in 1 BOTTLECAPSULE60104
71335-1822-3Pregabalin90 in 1 BOTTLECAPSULE90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1822-1EA - Each71335-1822dd2493f5-45ec-4677-97c6-6e89a7d726c412022-02-07
71335-1822-2EA - Each71335-1822349d0cc7-0668-4849-8003-63026c3d6d7612022-02-07
71335-1822-3EA - Each71335-1822fe4265bb-6c7c-4a65-a099-69f795e437ab12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1822PREGABALIN (PREGABALIN) CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 3 package rows20250406_b2d45d41-a787-4912-962d-0bd98b70d58a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483446pregabalin 200 MG Oral CapsulePSNb2d45d41-a787-4912-962d-0bd98b70d58a104
483446pregabalin 200 MG Oral CapsuleSCDb2d45d41-a787-4912-962d-0bd98b70d58a104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1822-17133518220130 CAPSULE in 1 BOTTLE (71335-1822-1) 30 capsule2021-04-220000-00-00NoNoCurrent
71335-1822-27133518220260 CAPSULE in 1 BOTTLE (71335-1822-2) 60 capsule2021-04-130000-00-00NoNoCurrent
71335-1822-37133518220390 CAPSULE in 1 BOTTLE (71335-1822-3) 90 capsule2021-04-150000-00-00NoNoCurrent