gliadel

Generic: carmustine

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

Drug Facts

Product Profile

Brand Name gliadel
Generic Name carmustine
Labeler azurity pharmaceuticals, inc.
Dosage Form WAFER
Routes
INTRACAVITARY
Active Ingredients

carmustine 7.7 mg/1

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 24338-050
Product ID 24338-050_288ecd1b-0244-dd13-e063-6394a90a739d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020637
Listing Expiration 2026-12-31
Marketing Start 2012-12-13

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24338050
Hyphenated Format 24338-050

Supplemental Identifiers

RxCUI
212994 309013
UNII
U68WG3173Y
NUI
N0000000236 N0000175558

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 gliadel (source: ndc)
Generic Name carmustine (source: ndc)
Application Number NDA020637 (source: ndc)
Routes
INTRACAVITARY
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/1
source: ndc
Packaging
  • 8 POUCH in 1 BOX (24338-050-08) / 1 WAFER in 1 POUCH
source: ndc

Packages (1)

24338-050-08 8 POUCH in 1 BOX (24338-050-08) / 1 WAFER in 1 POUCH

Ingredients (1)

carmustine (7.7 mg/1)

Linked Drug Pages (1)

Gliadel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRACAVITARY"], "spl_id": "288ecd1b-0244-dd13-e063-6394a90a739d", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["U68WG3173Y"], "rxcui": ["212994", "309013"], "spl_set_id": ["38962a55-a514-4c48-bea5-f99a8da4beec"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 POUCH in 1 BOX (24338-050-08)  / 1 WAFER in 1 POUCH", "package_ndc": "24338-050-08", "marketing_start_date": "20121213"}], "brand_name": "Gliadel", "product_id": "24338-050_288ecd1b-0244-dd13-e063-6394a90a739d", "dosage_form": "WAFER", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "24338-050", "generic_name": "carmustine", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gliadel", "active_ingredients": [{"name": "CARMUSTINE", "strength": "7.7 mg/1"}], "application_number": "NDA020637", "marketing_category": "NDA", "marketing_start_date": "20121213", "listing_expiration_date": "20261231"}