What is NDC 49315-008?

49315-008 is the product NDC for Doxorubicin Hydrochloride, Doxorubicin hydrochloride 2 mg/mL injectable, liposomal, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 49315. 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 49315-008

NDC codes

FDA NDC Directory

Product NDC (as listed)49315-008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49315-0008Add 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
49315-008-03	4931500080349315000803	1 VIAL, SINGLE-DOSE in 1 CARTON (49315-008-03) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 14, 2020

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: Injectable, Liposomal
Route: Intravenous
Labeler: Zydus Lifesciences LimitedNDC labeler code 49315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212299
Marketing start: Sep 14, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 49315-008_2c0f5abf-ca66-445c-9a35-e39b2111911eSPL ID 2c0f5abf-ca66-445c-9a35-e39b2111911eSPL set ID bad467d4-7e27-4eda-b4d3-854460f0adabRxCUI 1790115, 1790127UNII 82F2G7BL4E
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

N449315000803 followed by a unit qualifier and the quantity

Package 49315-0008-03. 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 Nov 1, 2022.

Full label on DailyMed (opens in a new tab)

About NDC 49315-008

What is NDC 49315-008?: 49315-008 is the product NDC for Doxorubicin Hydrochloride, Doxorubicin hydrochloride 2 mg/mL injectable, liposomal, listed with the FDA by Zydus Lifesciences Limited. 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?: Zydus Lifesciences Limited, NDC labeler code 49315. 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

Other NDCs under ANDA 212299

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212299
Product	Strength	Form · route	Labeler	Product NDC
Doxorubicin Hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injectable, LiposomalIntravenous	Zydus Lifesciences Limited	49315-009
Doxorubicin Hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injectable, LiposomalIntravenous	BluePoint Laboratories	68001-703
Doxorubicin Hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injectable, LiposomalIntravenous	BluePoint Laboratories	68001-704
Doxorubicin Hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injectable, LiposomalIntravenous	Zydus Pharmaceuticals USA Inc.	70710-1530
Doxorubicin Hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injectable, LiposomalIntravenous	Zydus Pharmaceuticals USA Inc.	70710-1531