NDC 46708-124

Pregabalin

Pregabalin

Pregabalin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Pregabalin.

Product ID46708-124_78a36538-701d-4dd9-a7fc-87d505784c83
NDC46708-124
Product TypeHuman Prescription Drug
Proprietary NamePregabalin
Generic NamePregabalin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-07-19
Marketing CategoryANDA / ANDA
Application NumberANDA203459
Labeler NameAlembic Pharmaceuticals Limited
Substance NamePREGABALIN
Active Ingredient Strength200 mg/1
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 46708-124-10

100 CAPSULE in 1 CARTON (46708-124-10)
Marketing Start Date2019-07-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-124-30 [46708012430]

Pregabalin CAPSULE
Marketing CategoryANDA
Application NumberANDA203459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-19

NDC 46708-124-90 [46708012490]

Pregabalin CAPSULE
Marketing CategoryANDA
Application NumberANDA203459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-19

NDC 46708-124-91 [46708012491]

Pregabalin CAPSULE
Marketing CategoryANDA
Application NumberANDA203459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-19

NDC 46708-124-10 [46708012410]

Pregabalin CAPSULE
Marketing CategoryANDA
Application NumberANDA203459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-19

Drug Details

Active Ingredients

IngredientStrength
PREGABALIN200 mg/1

OpenFDA Data

SPL SET ID:78a36538-701d-4dd9-a7fc-87d505784c83
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577127
  • 483438
  • 483448
  • 483442
  • 483440
  • 483450
  • 483446
  • 483444
  • UPC Code
  • 0346708122300
  • 0346708126308
  • 0346708125301
  • NDC Crossover Matching brand name "Pregabalin" or generic name "Pregabalin"

    NDCBrand NameGeneric Name
    61919-503PREGABALINPREGABALIN
    67877-457PregabalinPregabalin
    67877-469PregabalinPregabalin
    67877-468PregabalinPregabalin
    67877-466PregabalinPregabalin
    67877-465PregabalinPregabalin
    67877-464PregabalinPregabalin
    67877-467PregabalinPregabalin
    69097-962PregabalinPregabalin
    69097-959PregabalinPregabalin
    69097-958PregabalinPregabalin
    69097-957PregabalinPregabalin
    69097-961PregabalinPregabalin
    69097-956PregabalinPregabalin
    69097-954PregabalinPregabalin
    69097-955PregabalinPregabalin
    69238-1311PregabalinPregabalin
    69238-1315PregabalinPregabalin
    69238-1312PregabalinPregabalin
    69238-1314PregabalinPregabalin
    69238-1313PregabalinPregabalin
    69238-1310PregabalinPregabalin
    69238-1316PregabalinPregabalin
    69238-1317PregabalinPregabalin
    69539-018PregabalinPregabalin
    69539-013PregabalinPregabalin
    69539-015PregabalinPregabalin
    69539-017PregabalinPregabalin
    69539-016PregabalinPregabalin
    69539-012PregabalinPregabalin
    69539-014PregabalinPregabalin
    69539-011PregabalinPregabalin
    72205-013PregabalinPregabalin
    72205-015PregabalinPregabalin
    72205-017PregabalinPregabalin
    72189-023PREGABALINPREGABALIN
    72205-012PregabalinPregabalin
    72189-019PREGABALINPREGABALIN
    72205-014PregabalinPregabalin
    72205-011PregabalinPregabalin
    72189-020PREGABALINPREGABALIN
    72189-021PREGABALINPREGABALIN
    72205-018PregabalinPregabalin
    72205-016PregabalinPregabalin
    0071-1012LyricaPREGABALIN
    0071-1013LyricaPREGABALIN
    0071-1014LyricaPREGABALIN
    0071-1015LyricaPREGABALIN
    0071-1016LyricaPREGABALIN
    0071-1017LyricaPREGABALIN

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.