Cladribine
- Product NDC
- 42658-010
- 11-digit product format
- 426580010
- Labeler code
- 42658
- Product ID
- 42658-010_2c5c0edf-8718-40f2-e063-6294a90aacd0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cladribine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hisun Pharmaceuticals USA, Inc.
- Application
- ANDA210856
- Marketing category
- ANDA
- Marketing start
- 2020-05-18
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42658-010-01 | Cladribine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 6 |
| 42658-010-91 | Cladribine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42658-010 | CLADRIBINE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240228_71c39b37-33b5-42e1-bf4f-93ff751cc7fe.zip |
| 42658-010 | CLADRIBINE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250125_f538cba9-001a-4a21-e053-2a95a90a00ec.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 |
|---|
| 42658-010-01 | 42658001001 | 1 mL in 1 VIAL, SINGLE-DOSE (42658-010-01) | 1 ml | 2020-05-18 | 0000-00-00 | No | No | Current |
| 42658-010-91 | 42658001091 | 1 mL in 1 VIAL, SINGLE-DOSE (42658-010-91) | 1 ml | 2023-02-28 | | No | No | Current |