NDC 55056-0406

Prochieve

Progesterone

Prochieve is a Vaginal Gel in the Human Prescription Drug category. It is labeled and distributed by Columbia Laboratories. The primary component is Progesterone.

Product ID55056-0406_6ea8a930-2eae-435e-b13c-f2c9e9a4bf00
NDC55056-0406
Product TypeHuman Prescription Drug
Proprietary NameProchieve
Generic NameProgesterone
Dosage FormGel
Route of AdministrationVAGINAL
Marketing Start Date1997-05-13
Marketing CategoryNDA / NDA
Application NumberNDA020701
Labeler NameColumbia Laboratories
Substance NamePROGESTERONE
Active Ingredient Strength45 mg/1.125g
Pharm ClassesProgesterone [CS],Progesterone [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 55056-0406-1

6 APPLICATOR in 1 CARTON (55056-0406-1) > 1.125 g in 1 APPLICATOR
Marketing Start Date1997-05-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55056-0406-1 [55056040601]

Prochieve GEL
Marketing CategoryNDA
Application NumberNDA020701
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-05-13
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
PROGESTERONE45 mg/1.125g

OpenFDA Data

SPL SET ID:9f8dc923-65d7-42ff-b718-97e7a7e87822
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312643
  • 404323
  • 351825
  • 312645
  • Pharmacological Class

    • Progesterone [CS]
    • Progesterone [EPC]

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

    NDCBrand NameGeneric Name
    55056-1601ProchieveProchieve
    55056-0406ProchieveProchieve
    0023-6150Crinoneprogesterone
    0023-6151Crinoneprogesterone
    52544-255Crinoneprogesterone
    52544-256Crinoneprogesterone
    43857-0084Natural ProgesteroneProgesterone
    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
    44911-0047Progesterone PhenolicProgesterone

    Trademark Results [Prochieve]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROCHIEVE
    PROCHIEVE
    76413125 2762705 Dead/Cancelled
    ALLERGAN SALES, LLC
    2002-05-29

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