medroxyprogesterone acetate

Generic: medroxyprogesterone acetate

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

medroxyprogesterone acetate 150 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-329
Product ID 55150-329_2db6b7cc-c245-4ea2-a117-ff231d6c5b95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212824
Listing Expiration 2027-12-31
Marketing Start 2022-08-22

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150329
Hyphenated Format 55150-329

Supplemental Identifiers

RxCUI
1000126 1000153
UPC
0355150330010 0355150329014
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 ANDA212824 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 150 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-329-01) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-329-25) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

55150-329-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-329-01) / 1 mL in 1 VIAL, SINGLE-DOSE 55150-329-25 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-329-25) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "2db6b7cc-c245-4ea2-a117-ff231d6c5b95", "openfda": {"upc": ["0355150330010", "0355150329014"], "unii": ["C2QI4IOI2G"], "rxcui": ["1000126", "1000153"], "spl_set_id": ["0655670a-d127-4e08-8a23-ace64b2503b2"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-329-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-329-01", "marketing_start_date": "20220822"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-329-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-329-25", "marketing_start_date": "20220822"}], "brand_name": "MEDROXYPROGESTERONE ACETATE", "product_id": "55150-329_2db6b7cc-c245-4ea2-a117-ff231d6c5b95", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "55150-329", "generic_name": "MEDROXYPROGESTERONE ACETATE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MEDROXYPROGESTERONE ACETATE", "active_ingredients": [{"name": "MEDROXYPROGESTERONE ACETATE", "strength": "150 mg/mL"}], "application_number": "ANDA212824", "marketing_category": "ANDA", "marketing_start_date": "20220822", "listing_expiration_date": "20271231"}