Gliadel
- Product NDC
- 24338-050
- 11-digit product format
- 243380050
- Labeler code
- 24338
- Product ID
- 24338-050_288ecd1b-0244-dd13-e063-6394a90a739d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carmustine
- Dosage form
- WAFER
- Route
- INTRACAVITARY
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA020637
- Marketing category
- NDA
- Marketing start
- 2012-12-13
- Substance
- CARMUSTINE
- Active strength
- 7.7 mg/1
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gliadel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARMUSTINE | 7.7 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U68WG3173Y |
| Rxcui | 212994, 309013 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24338-050-08 | Gliadel | 1 in 1 POUCH | WAFER | 1 | | 8 |
| 24338-050-08 | Gliadel | 8 in 1 BOX | WAFER | 8 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24338-050 | GLIADEL (CARMUSTINE) WAFER [AZURITY PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241208_38962a55-a514-4c48-bea5-f99a8da4beec.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 24338-050-08 | 24338005008 | 8 POUCH in 1 BOX (24338-050-08) / 1 WAFER in 1 POUCH | 8 pouch | 2012-12-13 | 0000-00-00 | No | No | Current |