Prescription drug · ANDA
Dexrazoxane (Dexrazoxane for injection) NDC 68083-388
Dexrazoxane hydrochloride 250 mg/25mL · Injection, Powder, Lyophilized, For solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-388-01 | 6808303880168083038801 | 1 VIAL in 1 CARTON (68083-388-01) / 25 mL in 1 VIALMarketed from Dec 16, 2019 |
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)
- Dexrazoxane
- Generic name (nonproprietary)
- dexrazoxane for injection
- Active ingredients
- Dexrazoxane hydrochloride — 250 mg/25mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207321
- Marketing start
- Listing expires
- Identifiers
- Product ID 68083-388_31a8c608-3ad6-44fe-aec8-621a8b991677SPL ID 31a8c608-3ad6-44fe-aec8-621a8b991677SPL set ID c9c625fc-8852-4ed4-bcf2-63f46a706782RxCUI 1736585, 1736590UNII 5346058Q7SUPC 0368083388010, 0368083195014
- Pharmacologic class
- Cytoprotective Agent
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
N468083038801followed by a unit qualifier and the quantityPackage 68083-0388-01. 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 .
Indications (excerpt from the label)
Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2) ]. Dexrazoxane for injection is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue …
Excerpt only. Read the full label for complete information.
About NDC 68083-388
- What is NDC 68083-388?
- 68083-388 is the product NDC for Dexrazoxane (dexrazoxane for injection), Dexrazoxane hydrochloride 250 mg/25mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexrazoxane (Dexrazoxane for Injection).
- What is the active ingredient?
- Dexrazoxane hydrochloride.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexrazoxane?
- 10 other product NDCs are listed under this name. See all Dexrazoxane NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexrazoxane products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexrazoxane | Dexrazoxane hydrochloride 250 mg/25mL | Injection, Powder, Lyophilized, For solutionIntravenous | Novadoz Pharmaceuticals LLC | 72205-247 | 72205-0247-01 |
| Dexrazoxane | Dexrazoxane hydrochloride 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | Novadoz Pharmaceuticals LLC | 72205-248 | 72205-0248-01 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | Almaject, Inc. | 72611-716 | 72611-0716-72 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 250 mg/25mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fosun Pharma USA Inc. | 72266-235 | 72266-0235-01 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fosun Pharma USA Inc. | 72266-101 | 72266-0101-01 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-195 | 68083-0195-01 |
| Dexrazoxane | — | Kit | Eugia US LLC | 55150-434 | 55150-0434-02 |
| Dexrazoxane | — | Kit | Eugia US LLC | 55150-437 | 55150-0437-01 |
| Dexrazoxane | Dexrazoxane hydrochloride 250 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9247 | 00143-9247-01 |
| Dexrazoxane | Dexrazoxane hydrochloride 500 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9248 | 00143-9248-01 |
Other NDCs under ANDA 207321
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-195 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fosun Pharma USA Inc. | 72266-101 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 250 mg/25mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fosun Pharma USA Inc. | 72266-235 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | Almaject, Inc. | 72611-716 |