cortrosyn

Generic: cosyntropin

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

Drug Facts

Product Profile

Brand Name cortrosyn
Generic Name cosyntropin
Labeler amphastar pharmaceuticals, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

cosyntropin .25 mg/mL

Manufacturer
Amphastar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0548-5900
Product ID 0548-5900_089a373b-a63a-4575-8065-fdef2fc6c575
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016750
Listing Expiration 2026-12-31
Marketing Start 2003-08-01

Pharmacologic Class

Established (EPC)
adrenocorticotropic hormone [epc]
Chemical Structure
adrenocorticotropic hormone [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05485900
Hyphenated Format 0548-5900

Supplemental Identifiers

UNII
72YY86EA29
NUI
M0000499 N0000175941

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 cortrosyn (source: ndc)
Generic Name cosyntropin (source: ndc)
Application Number NDA016750 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0548-5900-00) / 1 mL in 1 VIAL
source: ndc

Packages (1)

0548-5900-00 10 VIAL in 1 CARTON (0548-5900-00) / 1 mL in 1 VIAL

Ingredients (1)

cosyntropin (.25 mg/mL)

Linked Drug Pages (1)

Cortrosyn ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "089a373b-a63a-4575-8065-fdef2fc6c575", "openfda": {"nui": ["M0000499", "N0000175941"], "unii": ["72YY86EA29"], "spl_set_id": ["746856e9-3930-4f6a-b8e6-a03845d6dd0b"], "pharm_class_cs": ["Adrenocorticotropic Hormone [CS]"], "pharm_class_epc": ["Adrenocorticotropic Hormone [EPC]"], "manufacturer_name": ["Amphastar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0548-5900-00)  / 1 mL in 1 VIAL", "package_ndc": "0548-5900-00", "marketing_start_date": "20030801"}], "brand_name": "Cortrosyn", "product_id": "0548-5900_089a373b-a63a-4575-8065-fdef2fc6c575", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Adrenocorticotropic Hormone [CS]", "Adrenocorticotropic Hormone [EPC]"], "product_ndc": "0548-5900", "generic_name": "Cosyntropin", "labeler_name": "Amphastar Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cortrosyn", "active_ingredients": [{"name": "COSYNTROPIN", "strength": ".25 mg/mL"}], "application_number": "NDA016750", "marketing_category": "NDA", "marketing_start_date": "20030801", "listing_expiration_date": "20261231"}