medroxyprogesterone acetate

Generic: medroxyprogesterone acetate

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name medroxyprogesterone acetate
Generic Name medroxyprogesterone acetate
Labeler mylan institutional llc
Dosage Form INJECTION, SUSPENSION
Routes
INTRAMUSCULAR
Active Ingredients

medroxyprogesterone acetate 150 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-887
Product ID 67457-887_e991ce3c-100b-2015-f61e-676217681e0f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210227
Listing Expiration 2026-12-31
Marketing Start 2018-10-12

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457887
Hyphenated Format 67457-887

Supplemental Identifiers

RxCUI
1000126
UPC
0367457887999
UNII
C2QI4IOI2G

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name medroxyprogesterone acetate (source: ndc)
Generic Name medroxyprogesterone acetate (source: ndc)
Application Number ANDA210227 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 150 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (67457-887-01) / 1 mL in 1 VIAL (67457-887-00)
  • 1 VIAL in 1 CARTON (67457-887-99) / 1 mL in 1 VIAL (67457-887-00)
source: ndc

Packages (2)

67457-887-01 25 VIAL in 1 CARTON (67457-887-01) / 1 mL in 1 VIAL (67457-887-00) 67457-887-99 1 VIAL in 1 CARTON (67457-887-99) / 1 mL in 1 VIAL (67457-887-00)

Ingredients (1)

medroxyprogesterone acetate (150 mg/mL)

Linked Drug Pages (1)

Medroxyprogesterone Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "e991ce3c-100b-2015-f61e-676217681e0f", "openfda": {"upc": ["0367457887999"], "unii": ["C2QI4IOI2G"], "rxcui": ["1000126"], "spl_set_id": ["60aba812-59eb-4d40-9b6b-d135dca9d36b"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (67457-887-01)  / 1 mL in 1 VIAL (67457-887-00)", "package_ndc": "67457-887-01", "marketing_start_date": "20181012"}, {"sample": false, "description": "1 VIAL in 1 CARTON (67457-887-99)  / 1 mL in 1 VIAL (67457-887-00)", "package_ndc": "67457-887-99", "marketing_start_date": "20181012"}], "brand_name": "Medroxyprogesterone Acetate", "product_id": "67457-887_e991ce3c-100b-2015-f61e-676217681e0f", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "67457-887", "generic_name": "Medroxyprogesterone Acetate", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Medroxyprogesterone Acetate", "active_ingredients": [{"name": "MEDROXYPROGESTERONE ACETATE", "strength": "150 mg/mL"}], "application_number": "ANDA210227", "marketing_category": "ANDA", "marketing_start_date": "20181012", "listing_expiration_date": "20261231"}