medroxyprogesterone acetate

Generic: medroxyprogesterone acetate

Labeler: amphastar pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name medroxyprogesterone acetate
Generic Name medroxyprogesterone acetate
Labeler amphastar pharmaceuticals, inc.
Dosage Form INJECTION, SUSPENSION, EXTENDED RELEASE
Routes
INTRAMUSCULAR
Active Ingredients

medroxyprogesterone acetate 150 mg/mL

Manufacturer
Amphastar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0548-5701
Product ID 0548-5701_fe3eb29d-0024-4834-a1af-81661804f532
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077334
Listing Expiration 2026-12-31
Marketing Start 2017-11-28

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05485701
Hyphenated Format 0548-5701

Supplemental Identifiers

RxCUI
1000126 1000153
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 ANDA077334 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 150 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (0548-5701-00) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

0548-5701-00 1 SYRINGE in 1 CARTON (0548-5701-00) / 1 mL in 1 SYRINGE

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": "fe3eb29d-0024-4834-a1af-81661804f532", "openfda": {"unii": ["C2QI4IOI2G"], "rxcui": ["1000126", "1000153"], "spl_set_id": ["fda1aa8a-5739-482a-b4f6-9741ef4d9977"], "manufacturer_name": ["Amphastar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (0548-5701-00)  / 1 mL in 1 SYRINGE", "package_ndc": "0548-5701-00", "marketing_start_date": "20171128"}], "brand_name": "Medroxyprogesterone Acetate", "product_id": "0548-5701_fe3eb29d-0024-4834-a1af-81661804f532", "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0548-5701", "generic_name": "Medroxyprogesterone acetate", "labeler_name": "Amphastar Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Medroxyprogesterone Acetate", "active_ingredients": [{"name": "MEDROXYPROGESTERONE ACETATE", "strength": "150 mg/mL"}], "application_number": "ANDA077334", "marketing_category": "ANDA", "marketing_start_date": "20171128", "listing_expiration_date": "20261231"}