NDC 0054-0401

Desvenlafaxine

Desvenlafaxine

Desvenlafaxine is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Desvenlafaxine Succinate.

Product ID0054-0401_2a8e1805-b94a-4ad5-bb8d-bf25c139606d
NDC0054-0401
Product TypeHuman Prescription Drug
Proprietary NameDesvenlafaxine
Generic NameDesvenlafaxine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA204083
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameDESVENLAFAXINE SUCCINATE
Active Ingredient Strength100 mg/1
Pharm ClassesNorepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0054-0401-13

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-13)
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0401-22 [00054040122]

Desvenlafaxine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204083
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-01

NDC 0054-0401-20 [00054040120]

Desvenlafaxine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204083
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01
Marketing End Date2017-03-01

NDC 0054-0401-06 [00054040106]

Desvenlafaxine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204083
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01
Marketing End Date2017-03-01

NDC 0054-0401-13 [00054040113]

Desvenlafaxine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204083
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-01

Drug Details

Active Ingredients

IngredientStrength
DESVENLAFAXINE SUCCINATE100 mg/1

OpenFDA Data

SPL SET ID:662890ff-d254-40e0-a9fe-f07ab94d65d6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1607617
  • 1874553
  • 1874559
  • UPC Code
  • 0300540603137
  • Pharmacological Class

    • Norepinephrine Uptake Inhibitors [MoA]
    • Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
    • Serotonin Uptake Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]

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

    NDCBrand NameGeneric Name
    0054-0400DesvenlafaxineDesvenlafaxine
    0054-0401DesvenlafaxineDesvenlafaxine
    0054-0603DesvenlafaxineDesvenlafaxine
    0378-4230Desvenlafaxinedesvenlafaxine
    0378-4231Desvenlafaxinedesvenlafaxine
    0591-3659DesvenlafaxineDesvenlafaxine
    0591-3660DesvenlafaxineDesvenlafaxine
    0591-4060DesvenlafaxineDesvenlafaxine
    35208-009DesvenlafaxineDesvenlafaxine
    35208-010DesvenlafaxineDesvenlafaxine
    44183-880Desvenlafaxinedesvenlafaxine
    44183-890Desvenlafaxinedesvenlafaxine
    46708-152DesvenlafaxineDesvenlafaxine
    46708-153DesvenlafaxineDesvenlafaxine
    46708-540DesvenlafaxineDesvenlafaxine Succinate
    46708-541DesvenlafaxineDesvenlafaxine Succinate
    46708-542DesvenlafaxineDesvenlafaxine Succinate
    50090-4388DesvenlafaxineDesvenlafaxine
    50090-4806DesvenlafaxineDesvenlafaxine
    68151-5295DesvenlafaxineDesvenlafaxine
    68382-469DesvenlafaxineDesvenlafaxine
    68382-741DesvenlafaxineDesvenlafaxine
    68788-7175DesvenlafaxineDesvenlafaxine
    68788-7194DesvenlafaxineDesvenlafaxine
    70771-1312DesvenlafaxineDesvenlafaxine
    70771-1311DesvenlafaxineDesvenlafaxine
    71335-0798DesvenlafaxineDesvenlafaxine
    51407-021DesvenlafaxineDesvenlafaxine
    51407-023DesvenlafaxineDesvenlafaxine
    51407-022DesvenlafaxineDesvenlafaxine
    51991-311DesvenlafaxineDesvenlafaxine
    51991-312DesvenlafaxineDesvenlafaxine
    51991-006DesvenlafaxineDesvenlafaxine
    55700-577DesvenlafaxineDesvenlafaxine
    63304-192DesvenlafaxineDesvenlafaxine
    63304-191DesvenlafaxineDesvenlafaxine
    63629-7559DesvenlafaxineDesvenlafaxine
    63629-7525DesvenlafaxineDesvenlafaxine
    70518-2244DesvenlafaxineDesvenlafaxine

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