hydroxyprogesterone caproate

Generic: hydroxyprogesterone caproate

Labeler: auromedics pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyprogesterone caproate
Generic Name hydroxyprogesterone caproate
Labeler auromedics pharma llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

hydroxyprogesterone caproate 1250 mg/5mL

Manufacturer
AuroMedics Pharma LLC

Identifiers & Regulatory

Product NDC 55150-311
Product ID 55150-311_b8f27635-ad16-41d2-a667-eaf51437947a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211142
Listing Expiration 2026-12-31
Marketing Start 2019-05-09

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150311
Hyphenated Format 55150-311

Supplemental Identifiers

RxCUI
1087964
UNII
276F2O42F5

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 hydroxyprogesterone caproate (source: ndc)
Generic Name hydroxyprogesterone caproate (source: ndc)
Application Number ANDA211142 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 1250 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (55150-311-01) / 5 mL in 1 VIAL
  • 5 VIAL in 1 CARTON (55150-311-05) / 5 mL in 1 VIAL
source: ndc

Packages (2)

55150-311-01 1 VIAL in 1 CARTON (55150-311-01) / 5 mL in 1 VIAL 55150-311-05 5 VIAL in 1 CARTON (55150-311-05) / 5 mL in 1 VIAL

Ingredients (1)

hydroxyprogesterone caproate (1250 mg/5mL)

Linked Drug Pages (1)

Hydroxyprogesterone Caproate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "b8f27635-ad16-41d2-a667-eaf51437947a", "openfda": {"unii": ["276F2O42F5"], "rxcui": ["1087964"], "spl_set_id": ["687bcf42-f437-42c7-8909-a91f621f55df"], "manufacturer_name": ["AuroMedics Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (55150-311-01)  / 5 mL in 1 VIAL", "package_ndc": "55150-311-01", "marketing_start_date": "20190509"}, {"sample": false, "description": "5 VIAL in 1 CARTON (55150-311-05)  / 5 mL in 1 VIAL", "package_ndc": "55150-311-05", "marketing_start_date": "20190509"}], "brand_name": "Hydroxyprogesterone Caproate", "product_id": "55150-311_b8f27635-ad16-41d2-a667-eaf51437947a", "dosage_form": "INJECTION", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "55150-311", "generic_name": "Hydroxyprogesterone Caproate", "labeler_name": "AuroMedics Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyprogesterone Caproate", "active_ingredients": [{"name": "HYDROXYPROGESTERONE CAPROATE", "strength": "1250 mg/5mL"}], "application_number": "ANDA211142", "marketing_category": "ANDA", "marketing_start_date": "20190509", "listing_expiration_date": "20261231"}