NDC 43353-257

Celecoxib

Celecoxib

Celecoxib is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Celecoxib.

Product ID43353-257_e3381eee-5310-4f22-ae15-a059905f2c83
NDC43353-257
Product TypeHuman Prescription Drug
Proprietary NameCelecoxib
Generic NameCelecoxib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-11-09
Marketing CategoryANDA / ANDA
Application NumberANDA078857
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameCELECOXIB
Active Ingredient Strength200 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-257-30

30 CAPSULE in 1 BOTTLE, PLASTIC (43353-257-30)
Marketing Start Date2016-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-257-30 [43353025730]

Celecoxib CAPSULE
Marketing CategoryANDA
Application NumberANDA078857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-15

NDC 43353-257-60 [43353025760]

Celecoxib CAPSULE
Marketing CategoryANDA
Application NumberANDA078857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-13

NDC 43353-257-53 [43353025753]

Celecoxib CAPSULE
Marketing CategoryANDA
Application NumberANDA078857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-13

Drug Details

Active Ingredients

IngredientStrength
CELECOXIB200 mg/1

OpenFDA Data

SPL SET ID:c5f4c4bf-f665-4b07-825a-51cc0ffb1788
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205323
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "Celecoxib" or generic name "Celecoxib"

    NDCBrand NameGeneric Name
    0093-7165CelecoxibCelecoxib
    0093-7166CelecoxibCelecoxib
    0093-7170CelecoxibCelecoxib
    0093-7306CelecoxibCelecoxib
    68071-2164CelecoxibCelecoxib
    68071-2169CelecoxibCelecoxib
    68071-4252CelecoxibCelecoxib
    68071-4392celecoxibcelecoxib
    68071-4642CELECOXIBCELECOXIB
    68071-4476CelecoxibCelecoxib
    68084-976CelecoxibCelecoxib
    68084-969CelecoxibCelecoxib
    68180-395celecoxibcelecoxib
    68180-396celecoxibcelecoxib
    68180-398celecoxibcelecoxib
    68180-397celecoxibcelecoxib
    68788-6393CELECOXIBCELECOXIB
    68788-6463CelecoxibCelecoxib
    68788-6941CelecoxibCelecoxib
    68788-9274CelecoxibCelecoxib
    68788-8936CelecoxibCelecoxib
    68788-7134CelecoxibCelecoxib
    68788-8924CelecoxibCelecoxib
    68788-9273CelecoxibCelecoxib
    68788-9993CelecoxibCelecoxib
    69097-421CELECOXIBCELECOXIB
    69097-420CELECOXIBCELECOXIB
    69097-422CELECOXIBCELECOXIB
    69097-423CELECOXIBCELECOXIB
    69677-154CelecoxibCelecoxib
    70518-1346celecoxibcelecoxib
    0591-3982CelecoxibCelecoxib
    70518-1650celecoxibcelecoxib
    0591-3984CelecoxibCelecoxib
    0591-3985CelecoxibCelecoxib
    0591-3983CelecoxibCelecoxib
    70882-129CelecoxibCelecoxib
    70934-026CelecoxibCelecoxib
    71205-020CelecoxibCelecoxib
    71205-027celecoxibcelecoxib
    71205-055CelecoxibCelecoxib
    71335-0361CelecoxibCelecoxib
    71335-0597CelecoxibCelecoxib
    71335-0936celecoxibcelecoxib
    71335-0868celecoxibcelecoxib
    71335-0292CelecoxibCelecoxib
    71335-0450CELECOXIBCELECOXIB
    71335-0437CelecoxibCelecoxib
    71626-302CelecoxibCelecoxib
    71626-303CelecoxibCelecoxib

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