NDC 99207-463

Solodyn

Minocycline Hydrochloride

Solodyn is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Minocycline Hydrochloride.

Product ID99207-463_3c27c96e-5556-4f4e-9971-a3c2d75796c2
NDC99207-463
Product TypeHuman Prescription Drug
Proprietary NameSolodyn
Generic NameMinocycline Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-07-23
Marketing CategoryNDA / NDA
Application NumberNDA050808
Labeler NameBausch Health US LLC
Substance NameMINOCYCLINE HYDROCHLORIDE
Active Ingredient Strength65 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 99207-463-02

10 BOTTLE in 1 CARTON (99207-463-02) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2009-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 99207-463-02 [99207046302]

Solodyn TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA050808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-23

NDC 99207-463-30 [99207046330]

Solodyn TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA050808
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-23

NDC 99207-463-10 [99207046310]

Solodyn TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA050808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-23
Marketing End Date2009-12-15

NDC 99207-463-01 [99207046301]

Solodyn TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA050808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-23
Marketing End Date2016-06-01

Drug Details

Active Ingredients

IngredientStrength
MINOCYCLINE HYDROCHLORIDE65 mg/1

OpenFDA Data

SPL SET ID:1b9dfa57-f295-4038-8aec-8efc54817d07
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 629699
  • 1014018
  • 629695
  • 629697
  • 727452
  • 727451
  • 1014022
  • 858064
  • 858372
  • 1014024
  • 858374
  • 858062
  • 750172
  • 1013665
  • 1013662
  • 1013659
  • Pharmacological Class

    • Tetracycline-class Drug [EPC]
    • Tetracyclines [CS]

    Medicade Reported Pricing

    99207046330 SOLODYN ER 65 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Solodyn" or generic name "Minocycline Hydrochloride"

    NDCBrand NameGeneric Name
    99207-467SolodynSolodyn
    99207-463SolodynSolodyn
    99207-466SolodynSolodyn
    99207-464SolodynSolodyn
    99207-465SolodynSolodyn
    0093-2133Minocycline HydrochlorideMinocycline Hydrochloride
    0093-2134Minocycline HydrochlorideMinocycline Hydrochloride
    0093-7741Minocycline HydrochlorideMinocycline Hydrochloride
    0093-7742Minocycline HydrochlorideMinocycline Hydrochloride
    0093-7743Minocycline HydrochlorideMinocycline Hydrochloride
    0115-9935minocycline hydrochlorideminocycline hydrochloride
    0115-9936minocycline hydrochlorideminocycline hydrochloride
    0378-4293Minocycline Hydrochlorideminocycline hydrochloride
    0378-4294Minocycline Hydrochlorideminocycline hydrochloride
    0440-7805Minocycline hydrochlorideMinocycline hydrochloride
    0591-3153Minocycline HydrochlorideMinocycline Hydrochloride
    0591-5694Minocycline HydrochlorideMinocycline Hydrochloride
    0591-5695Minocycline HydrochlorideMinocycline Hydrochloride
    0781-5385Minocycline HydrochlorideMinocycline Hydrochloride
    0781-5386Minocycline HydrochlorideMinocycline Hydrochloride
    0781-5387Minocycline HydrochlorideMinocycline Hydrochloride
    0904-6888Minocycline HydrochlorideMinocycline Hydrochloride
    13668-482Minocycline HydrochlorideMinocycline Hydrochloride
    10631-330Ximinominocycline hydrochloride
    10631-331Ximinominocycline hydrochloride
    10631-332Ximinominocycline hydrochloride

    Trademark Results [Solodyn]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SOLODYN
    SOLODYN
    78883462 3332602 Dead/Cancelled
    Medicis Pharmaceutical Corporation
    2006-05-15
    SOLODYN
    SOLODYN
    78595583 3178331 Live/Registered
    Medicis Pharmaceutical Corporation
    2005-03-25

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