Cladribine
- Product NDC
- 63323-140
- 11-digit product format
- 633230140
- Labeler code
- 63323
- Product ID
- 63323-140_77a36c8d-5dde-47a1-a50c-77239395cee2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLADRIBINE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA076571
- Marketing category
- ANDA
- Marketing start
- 2004-12-01
- Substance
- CLADRIBINE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Purine Antimetabolite [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cladribine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLADRIBINE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 47M74X9YT5 |
| Rxcui | 240754 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-140-10 | Cladribine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 6 |
| 63323-140-10 | Cladribine | 1 in 1 CARTON | INJECTION | 1 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-140 | CLADRIBINE (CLADRIBINE) INJECTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241013_a2592a9b-bca6-4a5a-89c2-855a0634d5fe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-140-10 | 63323014010 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-140-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2004-12-01 | 0000-00-00 | No | No | Current |