medroxyprogesterone

Generic: medroxyprogesterone

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

Drug Facts

Product Profile

Brand Name medroxyprogesterone
Generic Name medroxyprogesterone
Labeler pharmpak, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

medroxyprogesterone acetate 10 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-805
Product ID 54348-805_eaa58b56-e846-aab7-e053-2995a90a49c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040159
Listing Expiration 2026-12-31
Marketing Start 2019-07-12

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54348805
Hyphenated Format 54348-805

Supplemental Identifiers

RxCUI
1000114
UNII
C2QI4IOI2G

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 (source: ndc)
Generic Name medroxyprogesterone (source: ndc)
Application Number ANDA040159 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-805-05) / 5 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-805-10) / 10 TABLET in 1 BOTTLE
source: ndc

Packages (2)

54348-805-05 1 BOTTLE in 1 BOX (54348-805-05) / 5 TABLET in 1 BOTTLE 54348-805-10 1 BOTTLE in 1 BOX (54348-805-10) / 10 TABLET in 1 BOTTLE

Ingredients (1)

medroxyprogesterone acetate (10 mg/1)

Linked Drug Pages (1)

Medroxyprogesterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eaa58b56-e846-aab7-e053-2995a90a49c2", "openfda": {"unii": ["C2QI4IOI2G"], "rxcui": ["1000114"], "spl_set_id": ["1403a9a9-c04a-432f-8819-4850f779312e"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-805-05)  / 5 TABLET in 1 BOTTLE", "package_ndc": "54348-805-05", "marketing_start_date": "20190712"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-805-10)  / 10 TABLET in 1 BOTTLE", "package_ndc": "54348-805-10", "marketing_start_date": "20190712"}], "brand_name": "Medroxyprogesterone", "product_id": "54348-805_eaa58b56-e846-aab7-e053-2995a90a49c2", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "54348-805", "generic_name": "MEDROXYPROGESTERONE", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Medroxyprogesterone", "active_ingredients": [{"name": "MEDROXYPROGESTERONE ACETATE", "strength": "10 mg/1"}], "application_number": "ANDA040159", "marketing_category": "ANDA", "marketing_start_date": "20190712", "listing_expiration_date": "20261231"}