NDC 55056-0806

Crinone

Progesterone

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

Product ID55056-0806_f2c9bbef-22b9-413b-930d-e84fbea8247b
NDC55056-0806
Product TypeHuman Prescription Drug
Proprietary NameCrinone
Generic NameProgesterone
Dosage FormGel
Route of AdministrationVAGINAL
Marketing Start Date1997-05-13
Marketing CategoryNDA / NDA
Application NumberNDA020701
Labeler NameColumbia Laboratories, Inc.
Substance NamePROGESTERONE
Active Ingredient Strength90 mg/1.125g
Pharm ClassesProgesterone [CS],Progesterone [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 55056-0806-2

6 APPLICATOR in 1 CARTON (55056-0806-2) > 1.125 g in 1 APPLICATOR
Marketing Start Date1997-05-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55056-0806-2 [55056080602]

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

Drug Details

Active Ingredients

IngredientStrength
PROGESTERONE90 mg/1.125g

OpenFDA Data

SPL SET ID:2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 153579
  • 153580
  • 312645
  • 312643
  • Pharmacological Class

    • Progesterone [CS]
    • Progesterone [EPC]

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

    NDCBrand NameGeneric Name
    0023-6150Crinoneprogesterone
    0023-6151Crinoneprogesterone
    52544-255Crinoneprogesterone
    52544-256Crinoneprogesterone
    55056-0806CrinoneCrinone
    55056-0808CrinoneCrinone
    55056-0818CrinoneCrinone
    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 [Crinone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CRINONE
    CRINONE
    74494324 2086161 Live/Registered
    ALLERGAN FINANCE, LLC
    1994-02-25

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