NDC 0245-0213

Midodrine Hydrochloride

Midodrine Hydrochloride

Midodrine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Midodrine Hydrochloride.

Product ID0245-0213_01c0b615-7db3-4b22-99f2-892ced09ac2d
NDC0245-0213
Product TypeHuman Prescription Drug
Proprietary NameMidodrine Hydrochloride
Generic NameMidodrine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2004-11-03
Marketing CategoryANDA / ANDA
Application NumberANDA076725
Labeler NameUpsher-Smith laboratories, LLC
Substance NameMIDODRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAdrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0245-0213-01

100 BLISTER PACK in 1 CARTON (0245-0213-01) > 1 TABLET in 1 BLISTER PACK (0245-0213-89)
Marketing Start Date2004-11-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0245-0213-11 [00245021311]

Midodrine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076725
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-11-03

NDC 0245-0213-01 [00245021301]

Midodrine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076725
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-11-03

NDC 0245-0213-89 [00245021389]

Midodrine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076725
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-05

Drug Details

Active Ingredients

IngredientStrength
MIDODRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:4c3517f3-1c68-4ade-b5f1-c488a3a335c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993462
  • 993470
  • 993466
  • UPC Code
  • 0302450212119
  • 0302450211112
  • Pharmacological Class

    • Adrenergic alpha-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "Midodrine Hydrochloride" or generic name "Midodrine Hydrochloride"

    NDCBrand NameGeneric Name
    0115-4211MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
    0115-4222MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
    0115-4233MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
    0245-0211Midodrine Hydrochloridemidodrine hydrochloride
    0245-0212Midodrine Hydrochloridemidodrine hydrochloride
    0245-0213Midodrine Hydrochloridemidodrine hydrochloride
    0378-1901Midodrine Hydrochloridemidodrine hydrochloride
    0378-1902Midodrine Hydrochloridemidodrine hydrochloride
    0378-1903Midodrine Hydrochloridemidodrine hydrochloride
    0615-5647Midodrine HydrochlorideMidodrine Hydrochloride
    0615-7559Midodrine HydrochlorideMidodrine Hydrochloride
    0615-7566Midodrine HydrochlorideMidodrine Hydrochloride
    0615-8291Midodrine HydrochlorideMidodrine Hydrochloride
    0615-8293Midodrine HydrochlorideMidodrine Hydrochloride
    0615-8358midodrine hydrochloridemidodrine
    0615-8382Midodrine HydrochlorideMidodrine Hydrochloride
    0615-8383Midodrine HydrochlorideMidodrine Hydrochloride
    0615-8384Midodrine HydrochlorideMidodrine Hydrochloride
    0615-8443MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
    0615-8444MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
    0615-8445MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
    68151-2958MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
    42291-561Midodrine HydrochlorideMidodrine Hydrochloride
    42291-616MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
    42291-560Midodrine HydrochlorideMidodrine Hydrochloride
    42291-562Midodrine HydrochlorideMidodrine Hydrochloride
    49884-849Midodrine HydrochlorideMidodrine Hydrochloride
    49884-874Midodrine HydrochlorideMidodrine Hydrochloride
    49884-814Midodrine HydrochlorideMidodrine Hydrochloride
    51079-453Midodrine HydrochlorideMidodrine Hydrochloride
    55154-5696Midodrine HydrochlorideMidodrine Hydrochloride
    60505-1325Midodrine HydrochlorideMidodrine Hydrochloride
    60505-1320Midodrine HydrochlorideMidodrine Hydrochloride
    60505-1321Midodrine HydrochlorideMidodrine Hydrochloride
    60687-387Midodrine HydrochlorideMidodrine Hydrochloride
    60687-409Midodrine HydrochlorideMidodrine Hydrochloride
    60687-398Midodrine HydrochlorideMidodrine Hydrochloride
    63629-6928Midodrine HydrochlorideMidodrine Hydrochloride
    64980-435Midodrine HydrochlorideMidodrine Hydrochloride
    64980-433Midodrine HydrochlorideMidodrine Hydrochloride
    64980-434Midodrine HydrochlorideMidodrine Hydrochloride
    63629-7983Midodrine HydrochlorideMidodrine Hydrochloride
    0904-6817Midodrine HydrochlorideMidodrine Hydrochloride
    0904-6818Midodrine HydrochlorideMidodrine Hydrochloride
    50268-563Midodrine HydrochlorideMidodrine Hydrochloride
    50268-561Midodrine HydrochlorideMidodrine Hydrochloride
    50268-562Midodrine HydrochlorideMidodrine Hydrochloride
    0904-6819Midodrine HydrochlorideMidodrine Hydrochloride
    52817-324Midodrine HydrochlorideMidodrine Hydrochloride
    52817-325Midodrine HydrochlorideMidodrine Hydrochloride

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