What is NDC 67457-436?

67457-436 is the product NDC for Doxorubicin Hydrochloride, Doxorubicin hydrochloride 2 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Doxorubicin Hydrochloride?

54 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Doxorubicin Hydrochloride NDC 67457-436

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-436Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0436Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
67457-436-50	6745704365067457043650	1 VIAL in 1 CARTON (67457-436-50) / 25 mL in 1 VIALMarketed from Feb 27, 2014

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): Doxorubicin Hydrochloride
Generic name (nonproprietary): doxorubicin hydrochloride
Active ingredients: Doxorubicin hydrochloride — 2 mg/mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Mylan Institutional LLCNDC labeler code 67457
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200170
Marketing start: Feb 27, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 67457-436_fa646028-c150-4d9b-80a8-8add851d684dSPL ID fa646028-c150-4d9b-80a8-8add851d684dSPL set ID 5f71f79a-4f14-472d-b982-e28c3ce8f972RxCUI 1790095, 1790103UNII 82F2G7BL4EUPC 0367457478104
Pharmacologic class: Anthracycline Topoisomerase 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.

How CPT relates to drug billing

NDC on a medical claim

N467457043650 followed by a unit qualifier and the quantity

Package 67457-0436-50. 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 Jul 1, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Doxorubicin hydrochloride, USP is an anthracycline topoisomerase II inhibitor indicated: • as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ). • for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms' tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67457-436

What is NDC 67457-436?: 67457-436 is the product NDC for Doxorubicin Hydrochloride, Doxorubicin hydrochloride 2 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Doxorubicin Hydrochloride.
What is the active ingredient?: Doxorubicin hydrochloride.
Who is the labeler?: Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Doxorubicin Hydrochloride?: 54 other product NDCs are listed under this name. See all Doxorubicin Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Doxorubicin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
doxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	BluePoint Laboratories	68001-706	68001-0706-36
doxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	BluePoint Laboratories	68001-707	68001-0707-26
Doxorubicin Hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injectable, LiposomalIntravenous	BluePoint Laboratories	68001-703	68001-0703-36
Doxorubicin Hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injectable, LiposomalIntravenous	BluePoint Laboratories	68001-704	68001-0704-26
doxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	Alembic Pharmaceuticals Limited	46708-525	46708-0525-25
doxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	Alembic Pharmaceuticals Limited	46708-810	46708-0810-10
doxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	Alembic Pharmaceuticals Inc.	62332-525	62332-0525-25
doxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	Alembic Pharmaceuticals Inc.	62332-810	62332-0810-10
doxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	Dr. Reddy's Laboratories Inc.	75907-363	75907-0363-01
doxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	Dr. Reddy's Laboratories Inc.	75907-364	75907-0364-01

All 55 Doxorubicin Hydrochloride NDCs