agamree

Generic: vamorolone

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

Drug Facts

Product Profile

Brand Name agamree
Generic Name vamorolone
Labeler catalyst pharmaceuticals, inc.
Dosage Form KIT
Routes
ORAL
Manufacturer
Catalyst Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 69616-264
Product ID 69616-264_628ea96b-88da-4dfe-a3fa-c695d31a8740
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215239
Listing Expiration 2027-12-31
Marketing Start 2024-02-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69616264
Hyphenated Format 69616-264

Supplemental Identifiers

RxCUI
2669804 2669810
UPC
0369616264382 0369616265389

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 agamree (source: ndc)
Generic Name vamorolone (source: ndc)
Application Number NDA215239 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/ml
  • 100 ml
  • 125 ml
  • 5 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (69616-264-38) * 100 mL in 1 BOTTLE, GLASS (69616-265-38)
source: ndc

Packages (1)

69616-264-38 1 KIT in 1 CARTON (69616-264-38) * 100 mL in 1 BOTTLE, GLASS (69616-265-38)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

AGAMREE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "628ea96b-88da-4dfe-a3fa-c695d31a8740", "openfda": {"upc": ["0369616264382", "0369616265389"], "rxcui": ["2669804", "2669810"], "spl_set_id": ["fb376f09-cf9c-42b5-b4dd-02d5bcd73211"], "manufacturer_name": ["Catalyst Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (69616-264-38)  *  100 mL in 1 BOTTLE, GLASS (69616-265-38)", "package_ndc": "69616-264-38", "marketing_start_date": "20240201"}], "brand_name": "AGAMREE", "product_id": "69616-264_628ea96b-88da-4dfe-a3fa-c695d31a8740", "dosage_form": "KIT", "product_ndc": "69616-264", "generic_name": "VAMOROLONE", "labeler_name": "Catalyst Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AGAMREE", "application_number": "NDA215239", "marketing_category": "NDA", "marketing_start_date": "20240201", "listing_expiration_date": "20271231"}