Carmustine
- Product NDC
- 68475-503
- 11-digit product format
- 684750503
- Labeler code
- 68475
- Product ID
- 68475-503_14b0f256-a380-424d-a9d4-fafb6ec0e246
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carmustine
- Dosage form
- KIT
- Labeler
- Navinta LLC
- Application
- ANDA210179
- Marketing category
- ANDA
- Marketing start
- 2020-12-29
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carmustine
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 309012 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68475-500-01 | Carmustine | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 30 mL | 100 mg in 30mL | 11 |
| 68475-503-01 | Carmustine | 1 in 1 CARTON | KIT | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68475-503 | CARMUSTINE (CARMUSTINE) KIT [NAVINTA LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241218_06a0322b-eb28-44e2-9925-88bebd8fa91b.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 |
|---|
| 68475-500-01 | 68475050001 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | | | | | Historical |
| 68475-503-01 | 68475050301 | 1 KIT in 1 CARTON (68475-503-01) * 3 mL in 1 VIAL (68475-502-01) * 30 mL in 1 VIAL, SINGLE-DOSE (68475-500-01) | 1 kit | 2020-12-29 | 0000-00-00 | No | No | Current |