Pregabalin

Product NDC
71205-872
11-digit product format
712050872
Labeler code
71205
Product ID
71205-872_1815296c-fc89-41c8-9079-ffb947b59b0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208677
Marketing category
ANDA
Marketing start
2021-08-24
Substance
PREGABALIN
Active strength
100 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

Related Records

Active Ingredients

IngredientStrength
PREGABALIN100 mg/1

Harmonized Identifiers

FieldValues
Unii55JG375S6M
Rxcui483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
55JG375S6MPREGABALIN148553-50-8PREGABALIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-872-0071205087200100 CAPSULE in 1 BOTTLE (71205-872-00) 100 capsule2021-12-210000-00-00NoNoCurrent
71205-872-11712050872111000 CAPSULE in 1 BOTTLE (71205-872-11) 1000 capsule2021-12-210000-00-00NoNoCurrent
71205-872-307120508723030 CAPSULE in 1 BOTTLE (71205-872-30) 30 capsule2021-12-210000-00-00NoNoCurrent
71205-872-5571205087255500 CAPSULE in 1 BOTTLE (71205-872-55) 500 capsule2021-12-210000-00-00NoNoCurrent
71205-872-607120508726060 CAPSULE in 1 BOTTLE (71205-872-60) 60 capsule2021-12-210000-00-00NoNoCurrent
71205-872-6771205087267270 CAPSULE in 1 BOTTLE (71205-872-67) 270 capsule2021-12-210000-00-00NoNoCurrent
71205-872-7271205087272120 CAPSULE in 1 BOTTLE (71205-872-72) 120 capsule2021-12-210000-00-00NoNoCurrent
71205-872-7871205087278180 CAPSULE in 1 BOTTLE (71205-872-78) 180 capsule2021-12-210000-00-00NoNoCurrent
71205-872-907120508729090 CAPSULE in 1 BOTTLE (71205-872-90) 90 capsule2021-12-210000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PregabalinAphena Pharma Solutions - Tennessee, LLC2025-10-27HUMAN PRESCRIPTION DRUG LABEL2
PregabalinProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL2