NDC 0641-6115

Oxytocin

Oxytocin

Oxytocin is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Oxytocin.

Product ID0641-6115_43bde17d-d249-4ad7-9136-a4ecd9dc648d
NDC0641-6115
Product TypeHuman Prescription Drug
Proprietary NameOxytocin
Generic NameOxytocin
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date1980-04-29
Marketing CategoryNDA / NDA
Application NumberNDA018243
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameOXYTOCIN
Active Ingredient Strength10 [USP'U]/mL
Pharm ClassesIncreased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0641-6115-25

25 VIAL in 1 CARTON (0641-6115-25) > 10 mL in 1 VIAL (0641-6115-01)
Marketing Start Date1980-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0641-6115-01 [00641611501]

Oxytocin INJECTION
Marketing CategoryNDA
Application NumberNDA018243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1980-04-29

NDC 0641-6115-25 [00641611525]

Oxytocin INJECTION
Marketing CategoryNDA
Application NumberNDA018243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1980-04-29

Drug Details

Active Ingredients

IngredientStrength
OXYTOCIN10 [USP'U]/mL

OpenFDA Data

SPL SET ID:a9b62187-4141-487c-a9da-f42ad7f9b408
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1791721
  • 238013
  • Pharmacological Class

    • Increased Uterine Smooth Muscle Contraction or Tone [PE]
    • Oxytocic [EPC]
    • Oxytocin [CS]

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

    NDCBrand NameGeneric Name
    0143-9742OxytocinOxytocin
    0143-9743OxytocinOxytocin
    0641-6114OxytocinOxytocin
    0641-6115OxytocinOxytocin
    52533-048OxytocinOxytocin
    52533-051OxytocinOxytocin
    52533-054OxytocinOxytocin
    52533-055OxytocinOxytocin
    52533-056OxytocinOxytocin
    52533-105OxytocinOxytocin
    52533-170OxytocinOxytocin
    52533-233OxytocinOxytocin
    52533-234OxytocinOxytocin
    55154-9356OxytocinOXYTOCIN
    55154-9577OxytocinOXYTOCIN
    55154-9584OxytocinOXYTOCIN
    63323-012OxytocinOXYTOCIN
    42023-116Pitocinoxytocin
    42023-130Pitocinoxytocin

    Trademark Results [Oxytocin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OXYTOCIN
    OXYTOCIN
    78368996 not registered Dead/Abandoned
    Hirsch, Eric Michael
    2004-02-17

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