Prescription drug · ANDA
Cytarabine NDC 71288-169
Cytarabine 20 mg/mL · Injection, Solution · Intravenous, Subcutaneous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-169-25 | 7128801692571288016925 | 1 VIAL, MULTI-DOSE in 1 CARTON (71288-169-25) / 25 mL in 1 VIAL, MULTI-DOSEMarketed from Feb 28, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cytarabine
- Generic name (nonproprietary)
- cytarabine
- Active ingredients
- Cytarabine — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Meitheal Pharmaceuticals Inc.NDC labeler code 71288
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208485
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 71288-169_bb497b35-a3a3-43e8-a187-6ad2851acf26SPL ID bb497b35-a3a3-43e8-a187-6ad2851acf26SPL set ID 8b366382-c8d1-4344-86b7-f65e92a8952bRxCUI 240416UNII 04079A1RDZ
- Pharmacologic class
- Nucleoside Metabolic Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N471288016925followed by a unit qualifier and the quantityPackage 71288-0169-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Cytarabine in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative-free only) is indicated for the prophylaxis and treatment of meningeal leukemia.
Excerpt only. Read the full label for complete information.
About NDC 71288-169
- What is NDC 71288-169?
- 71288-169 is the product NDC for Cytarabine, Cytarabine 20 mg/mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cytarabine.
- What is the active ingredient?
- Cytarabine.
- Who is the labeler?
- Meitheal Pharmaceuticals Inc., NDC labeler code 71288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cytarabine?
- 13 other product NDCs are listed under this name. See all Cytarabine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cytarabine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cytarabine | Cytarabine 100 mg/mL | Injection, SolutionIntrathecal, Intravenous, Subcutaneous | Hospira, Inc. | 61703-155 | 61703-0155-01 |
| cytarabine | Cytarabine 100 mg/mL | Injection, SolutionIntrathecal, Intravenous, Subcutaneous | Sagent Pharmaceuticals | 25021-223 | 25021-0223-20 |
| cytarabine | Cytarabine 20 mg/mL | Injection, SolutionIntrathecal, Intravenous, Subcutaneous | Sagent Pharmaceuticals | 25021-229 | 25021-0229-05 |
| Cytarabine | Cytarabine 20 mg/mL | Injection, SolutionIntrathecal, Intravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-108 | 71288-0108-06 |
| Cytarabine | Cytarabine 100 mg/mL | Injection, SolutionIntrathecal, Intravenous, Subcutaneous | Gland Pharma Limited | 68083-337 | 68083-0337-01 |
| Cytarabine | Cytarabine 20 mg/mL | Injection, SolutionIntrathecal, Intravenous, Subcutaneous | Gland Pharma Limited | 68083-343 | 68083-0343-05 |
| Cytarabine | Cytarabine 2 g/20mL | Injection, SolutionIntrathecal, Intravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-109 | 71288-0109-20 |
| Cytarabine | Cytarabine 20 mg/mL | Injection, SolutionIntravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-168 | 71288-0168-50 |
| Cytarabine | Cytarabine 100 mg/mL | Injection, SolutionIntrathecal, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-120 | 63323-0120-20 |
| Cytarabine | Cytarabine 100 mg/mL | Injection, SolutionIntrathecal, Intravenous, Subcutaneous | Hospira, Inc. | 61703-319 | 61703-0319-22 |