NDC 0548-5400

Medroxyprogesterone Acetate

Medroxyprogesterone Acetate

Medroxyprogesterone Acetate is a Intramuscular Injection, Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amphastar Pharmaceuticals, Inc.. The primary component is Medroxyprogesterone Acetate.

Product ID0548-5400_a7611012-8ab7-4054-82f2-071e00b35481
NDC0548-5400
Product TypeHuman Prescription Drug
Proprietary NameMedroxyprogesterone Acetate
Generic NameMedroxyprogesterone Acetate
Dosage FormInjection, Suspension, Extended Release
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2017-11-28
Marketing CategoryANDA / ANDA
Application NumberANDA077235
Labeler NameAmphastar Pharmaceuticals, Inc.
Substance NameMEDROXYPROGESTERONE ACETATE
Active Ingredient Strength150 mg/mL
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0548-5400-00

1 VIAL, SINGLE-DOSE in 1 CARTON (0548-5400-00) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-11-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0548-5400-00 [00548540000]

Medroxyprogesterone Acetate INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-28

NDC 0548-5400-25 [00548540025]

Medroxyprogesterone Acetate INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-27

Drug Details

Active Ingredients

IngredientStrength
MEDROXYPROGESTERONE ACETATE150 mg/mL

OpenFDA Data

SPL SET ID:fda1aa8a-5739-482a-b4f6-9741ef4d9977
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000153
  • 1000126

    • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]
    • Progesterone Congeners [CS]
    • Progestin [EPC]

    NDC Crossover Matching brand name "Medroxyprogesterone Acetate" or generic name "Medroxyprogesterone Acetate"

    NDCBrand NameGeneric Name
    0548-5400Medroxyprogesterone AcetateMedroxyprogesterone acetate
    0548-5410Medroxyprogesterone AcetateMedroxyprogesterone acetate
    68071-1818Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    68071-1870Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    68071-2175Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    68071-4132Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    68071-4666Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    68788-7401Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    68788-9233medroxyprogesterone acetatemedroxyprogesterone acetate
    68788-9899Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    69189-3741medroxyprogesterone acetatemedroxyprogesterone acetate
    69097-539MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE
    69189-3740medroxyprogesterone acetatemedroxyprogesterone acetate
    0548-5701Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    0555-0779Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    0555-0873Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    0555-0872Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    70518-0443medroxyprogesterone acetatemedroxyprogesterone acetate
    70518-1932medroxyprogesterone acetatemedroxyprogesterone acetate
    71205-118Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    0703-6801Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    10544-001Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    10544-062Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    21695-896Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    33261-609Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    33261-534Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    33261-740Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    43063-438medroxyprogesterone acetatemedroxyprogesterone acetate
    50090-0883medroxyprogesterone acetatemedroxyprogesterone acetate
    50090-0166Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    50090-0490Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    50090-0491Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    50090-3328medroxyprogesterone acetatemedroxyprogesterone acetate
    52125-915medroxyprogesterone acetatemedroxyprogesterone acetate
    53002-3570Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    55289-816medroxyprogesterone acetatemedroxyprogesterone acetate
    55289-160Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    55289-908medroxyprogesterone acetatemedroxyprogesterone acetate
    55700-699medroxyprogesterone acetatemedroxyprogesterone acetate
    59762-0055medroxyprogesterone acetatemedroxyprogesterone acetate
    59762-3740medroxyprogesterone acetatemedroxyprogesterone acetate
    59762-3742medroxyprogesterone acetatemedroxyprogesterone acetate
    59762-4538medroxyprogesterone acetatemedroxyprogesterone acetate
    59762-3741medroxyprogesterone acetatemedroxyprogesterone acetate
    59762-4537medroxyprogesterone acetatemedroxyprogesterone acetate
    60687-105Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    63187-382Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    63629-2612Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    63629-2614Medroxyprogesterone AcetateMedroxyprogesterone Acetate
    63629-6812Medroxyprogesterone AcetateMedroxyprogesterone Acetate
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