camcevi

Generic: leuprolide

Labeler: accord biopharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name camcevi
Generic Name leuprolide
Labeler accord biopharma, inc.
Dosage Form INJECTION, EMULSION
Routes
SUBCUTANEOUS
Active Ingredients

leuprolide mesylate 42 mg/.37g

Manufacturer
Accord BioPharma, Inc.

Identifiers & Regulatory

Product NDC 69448-014
Product ID 69448-014_4b1ada65-9911-eacf-e063-6394a90af9d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211488
Listing Expiration 2027-12-31
Marketing Start 2022-04-05

Pharmacologic Class

Classes
gonadotropin releasing hormone receptor agonist [epc] gonadotropin releasing hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69448014
Hyphenated Format 69448-014

Supplemental Identifiers

RxCUI
2595044 2595049
UNII
8E3C3C493W

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 camcevi (source: ndc)
Generic Name leuprolide (source: ndc)
Application Number NDA211488 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 42 mg/.37g
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (69448-014-63) / .37 g in 1 SYRINGE
source: ndc

Packages (1)

69448-014-63 1 SYRINGE in 1 CARTON (69448-014-63) / .37 g in 1 SYRINGE

Ingredients (1)

leuprolide mesylate (42 mg/.37g)

Linked Drug Pages (1)

CAMCEVI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "4b1ada65-9911-eacf-e063-6394a90af9d9", "openfda": {"unii": ["8E3C3C493W"], "rxcui": ["2595044", "2595049"], "spl_set_id": ["d7a8761a-d953-413a-e053-2a95a90a60ee"], "manufacturer_name": ["Accord BioPharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (69448-014-63)  / .37 g in 1 SYRINGE", "package_ndc": "69448-014-63", "marketing_start_date": "20220405"}], "brand_name": "CAMCEVI", "product_id": "69448-014_4b1ada65-9911-eacf-e063-6394a90af9d9", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["Gonadotropin Releasing Hormone Receptor Agonist [EPC]", "Gonadotropin Releasing Hormone Receptor Agonists [MoA]"], "product_ndc": "69448-014", "generic_name": "LEUPROLIDE", "labeler_name": "Accord BioPharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CAMCEVI", "active_ingredients": [{"name": "LEUPROLIDE MESYLATE", "strength": "42 mg/.37g"}], "application_number": "NDA211488", "marketing_category": "NDA", "marketing_start_date": "20220405", "listing_expiration_date": "20271231"}