NDC 0517-0750

Progesterone

Progesterone

Progesterone is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Progesterone.

Product ID0517-0750_67cbd1da-38b6-498e-a721-6fb2f4528a68
NDC0517-0750
Product TypeHuman Prescription Drug
Proprietary NameProgesterone
Generic NameProgesterone
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2010-09-29
Marketing CategoryANDA / ANDA
Application NumberANDA090845
Labeler NameAmerican Regent, Inc.
Substance NamePROGESTERONE
Active Ingredient Strength50 mg/mL
Pharm ClassesProgesterone [CS],Progesterone [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0517-0750-01

1 VIAL, MULTI-DOSE in 1 CARTON (0517-0750-01) > 10 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2010-09-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-0750-01 [00517075001]

Progesterone INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090845
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-09-29
Marketing End Date2014-12-03

Drug Details

Active Ingredients

IngredientStrength
PROGESTERONE50 mg/mL

OpenFDA Data

SPL SET ID:b79abe4a-0242-41da-b91b-df723b85f0cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312644
  • Pharmacological Class

    • Progesterone [CS]
    • Progesterone [EPC]

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

    NDCBrand NameGeneric Name
    0093-5353ProgesteroneProgesterone
    0093-5354ProgesteroneProgesterone
    0143-9725ProgesteroneProgesterone
    0517-0750ProgesteroneProgesterone
    0591-3128PROGESTERONEPROGESTERONE
    10888-7135PROGESTERONEPROGESTERONE
    10888-7136PROGESTERONEPROGESTERONE
    16714-157ProgesteroneProgesterone
    16714-158ProgesteroneProgesterone
    17478-766ProgesteroneProgesterone
    17478-767ProgesteroneProgesterone
    42291-690PROGESTERONEPROGESTERONE
    43598-349ProgesteroneProgesterone
    43598-350ProgesteroneProgesterone
    43742-0158ProgesteroneProgesterone
    43742-0762ProgesteroneProgesterone
    43742-0851ProgesteroneProgesterone
    43857-0103ProgesteroneProgesterone
    43857-0120ProgesteroneProgesterone
    50090-2325PROGESTERONEPROGESTERONE
    50090-2527ProgesteroneProgesterone
    50090-3240ProgesteroneProgesterone
    50090-4656ProgesteroneProgesterone
    50090-5928ProgesteroneProgesterone
    68071-2134PROGESTERONEPROGESTERONE
    68788-7199ProgesteroneProgesterone
    69387-101PROGESTERONEPROGESTERONE
    69387-102PROGESTERONEPROGESTERONE
    69452-148PROGESTERONEPROGESTERONE
    69452-233PROGESTERONEPROGESTERONE
    69452-234PROGESTERONEPROGESTERONE
    69543-374ProgesteroneProgesterone
    69452-149PROGESTERONEPROGESTERONE
    69543-375ProgesteroneProgesterone
    70518-1830ProgesteroneProgesterone
    71335-0713ProgesteroneProgesterone
    71335-0835ProgesteroneProgesterone
    71335-0825ProgesteroneProgesterone
    55150-306ProgesteroneProgesterone
    55714-6634ProgesteroneProgesterone
    59651-152ProgesteroneProgesterone
    59651-153ProgesteroneProgesterone
    60429-869ProgesteroneProgesterone
    60429-868ProgesteroneProgesterone
    63323-261ProgesteroneProgesterone
    63629-7475ProgesteroneProgesterone
    65162-807ProgesteroneProgesterone
    65162-808ProgesteroneProgesterone
    71205-293ProgesteroneProgesterone
    0023-6150Crinoneprogesterone

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