NDC 54348-805

Medroxyprogesterone

Medroxyprogesterone

Medroxyprogesterone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Medroxyprogesterone Acetate.

Product ID54348-805_8f769dbd-3164-66a6-e053-2a95a90a1911
NDC54348-805
Product TypeHuman Prescription Drug
Proprietary NameMedroxyprogesterone
Generic NameMedroxyprogesterone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-12
Marketing CategoryANDA / ANDA
Application NumberANDA040159
Labeler NamePharmPak, Inc.
Substance NameMEDROXYPROGESTERONE ACETATE
Active Ingredient Strength10 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54348-805-05

1 BOTTLE in 1 BOX (54348-805-05) > 5 TABLET in 1 BOTTLE
Marketing Start Date2019-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-805-10 [54348080510]

Medroxyprogesterone TABLET
Marketing CategoryANDA
Application NumberANDA040159
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-12

NDC 54348-805-05 [54348080505]

Medroxyprogesterone TABLET
Marketing CategoryANDA
Application NumberANDA040159
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-12

Drug Details

Active Ingredients

IngredientStrength
MEDROXYPROGESTERONE ACETATE10 mg/1

OpenFDA Data

SPL SET ID:1403a9a9-c04a-432f-8819-4850f779312e
Manufacturer
UNII

Pharmacological Class

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

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