Cladribine
- Product NDC
- 0143-9871
- 11-digit product format
- 001439871
- Labeler code
- 0143
- Product ID
- 0143-9871_5aef0cdc-fa27-47a1-8cce-2a3201aba276
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cladribine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA075405
- Marketing category
- ANDA
- Marketing start
- 2000-02-28
- 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 |
|---|
| 0143-9871-01 | Cladribine | 10 mL in 1 VIAL | INJECTION | 10 | | 5 |
| 0143-9871-01 | Cladribine | 1 in 1 BOX, UNIT-DOSE | INJECTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9871 | CLADRIBINE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230420_5736aecc-cc1d-47dd-86c0-5fb2e9d70f61.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 |
|---|
| 0143-9871-01 | 00143987101 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9871-01) / 10 mL in 1 VIAL | 1 vial | 2000-02-28 | 0000-00-00 | No | No | Current |