NDC 24338-050

Gliadel

Carmustine

Gliadel is a Intracavitary Wafer in the Human Prescription Drug category. It is labeled and distributed by Arbor Pharmaceuticals. The primary component is Carmustine.

• Product ID: 24338-050_38ee529a-9515-4e98-8722-5b6c848f7d74
• NDC: 24338-050
• Product Type: Human Prescription Drug
• Proprietary Name: Gliadel
• Generic Name: Carmustine
• Dosage Form: Wafer
• Route of Administration: INTRACAVITARY
• Marketing Start Date: 2012-12-13
• Marketing Category: NDA / NDA
• Application Number: NDA020637
• Labeler Name: Arbor Pharmaceuticals
• Substance Name: CARMUSTINE
• Active Ingredient Strength: 8 mg/1
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 24338-050-08

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

• Marketing Start Date: 2012-12-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 24338-050-08 [24338005008]

Gliadel WAFER

• Marketing Category: NDA
• Application Number: NDA020637
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-13

Drug Details

Active Ingredients

Ingredient	Strength
CARMUSTINE	7.7 mg/1

OpenFDA Data

• SPL SET ID: 38962a55-a514-4c48-bea5-f99a8da4beec
• Manufacturer:
  • Arbor Pharmaceuticals
• UNII:
  • U68WG3173Y
• RxNorm Concept Unique ID - RxCUI:
  • 309013
  • 212994

Pharmacological Class

• Alkylating Activity [MoA]
• Alkylating Drug [EPC]
• Alkylating Activity [MoA]
• Alkylating Drug [EPC]

NDC Crossover Matching brand name "Gliadel" or generic name "Carmustine"

NDC	Brand Name	Generic Name
24338-050	Gliadel	carmustine
23155-261	BiCNU	CARMUSTINE
0781-3474	CARMUSTINE	CARMUSTINE
16729-545	CARMUSTINE	CARMUSTINE
16729-548	CARMUSTINE	CARMUSTINE
23155-649	CARMUSTINE	CARMUSTINE
23155-790	CARMUSTINE	CARMUSTINE
43598-628	carmustine	carmustine
50742-492	CARMUSTINE	carmustine
54879-036	Carmustine	Carmustine
68475-503	Carmustine	carmustine
70121-1482	carmustine	carmustine
70710-1525	carmustine	carmustine
70860-223	Carmustine	carmustine
71288-126	Carmustine	Carmustine