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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
55JG375S6MPREGABALIN148553-50-8PREGABALIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-049-308280400493030 CAPSULE in 1 BOTTLE (82804-049-30) 30 capsule2023-12-21NoNoHistorical
82804-049-608280400496060 CAPSULE in 1 BOTTLE (82804-049-60) 60 capsule2023-12-21NoNoHistorical
82804-049-908280400499090 CAPSULE in 1 BOTTLE (82804-049-90) 90 capsule2023-12-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PregabalinProficient Rx LP2023-12-01HUMAN PRESCRIPTION DRUG LABEL1