Mercaptopurine
- Product NDC
- 0054-4581
- 11-digit product format
- 000544581
- Labeler code
- 0054
- Product ID
- 0054-4581_564261a6-c6b6-4d31-bf80-36fe086e73e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mercaptopurine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA040528
- Marketing category
- ANDA
- Marketing start
- 2004-02-13
- Substance
- MERCAPTOPURINE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mercaptopurine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MERCAPTOPURINE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | E7WED276I5 |
| Rxcui | 197931 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-4581-11 | Mercaptopurine | 25 in 1 BOTTLE, PLASTIC | TABLET | 25 | | 14 |
| 0054-4581-27 | Mercaptopurine | 250 in 1 BOTTLE, PLASTIC | TABLET | 250 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MERCAPTOPURINE | ACTIVE INGREDIENT | E7WED276I5 | MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| MERCAPTOPURINE ANHYDROUS | ACTIVE MOIETY | PKK6MUZ20G | MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| STARCH, POTATO | INACTIVE INGREDIENT | 8I089SAH3T | MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-4581 | MERCAPTOPURINE TABLET [HIKMA PHARMACEUTICALS USA INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250315_c3b5b8b0-bc5c-4ce9-bbdc-febba60c2658.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 |
|---|
| 0054-4581-11 | 00054458111 | 25 TABLET in 1 BOTTLE, PLASTIC (0054-4581-11) | 25 tablet | 2004-02-13 | 0000-00-00 | No | No | Current |
| 0054-4581-27 | 00054458127 | 250 TABLET in 1 BOTTLE, PLASTIC (0054-4581-27) | 250 tablet | 2004-02-13 | 0000-00-00 | No | No | Current |