FDA.reportPublic FDA data

Pregabalin

Product NDC
82804-049
11-digit product format
828040049
Labeler code
82804
Product ID
82804-049_38e80423-0194-4064-9447-abfd29fce1da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
25 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
PREGABALIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483442

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
82804-049-30Pregabalin30 in 1 BOTTLECAPSULE301
82804-049-60Pregabalin60 in 1 BOTTLECAPSULE601
82804-049-90Pregabalin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-049-60EA - Each82804-049731f8b9f-2b62-44b6-85fa-47fd3ae9b04c12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-049PREGABALIN CAPSULE [PROFICIENT RX LP]1Current NDC, 3 package rows20231230_38e80423-0194-4064-9447-abfd29fce1da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483442pregabalin 25 MG Oral CapsulePSN38e80423-0194-4064-9447-abfd29fce1da1
483442pregabalin 25 MG Oral CapsuleSCD38e80423-0194-4064-9447-abfd29fce1da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-049-308280400493030 CAPSULE in 1 BOTTLE (82804-049-30) 30 capsule2023-12-21NoNoCurrent
82804-049-608280400496060 CAPSULE in 1 BOTTLE (82804-049-60) 60 capsule2023-12-21NoNoCurrent
82804-049-908280400499090 CAPSULE in 1 BOTTLE (82804-049-90) 90 capsule2023-12-21NoNoCurrent