What is NDC 63323-101?

63323-101 is the product NDC for Doxorubicin Hydrochloride, Doxorubicin hydrochloride 2 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 63323-101

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0101Add 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
63323-101-61	6332301016163323010161	1 VIAL, MULTI-DOSE in 1 CARTON (63323-101-61) / 100 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 14, 2000

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, Solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 063277
Marketing start: Jun 14, 2000
Listing expires: Dec 31, 2027
Other FDA classes: Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 63323-101_89998b96-8ca7-4eb1-98a4-e533420d0e72SPL ID 89998b96-8ca7-4eb1-98a4-e533420d0e72SPL set ID e0349f98-42fa-4003-b6d8-a1db1401b0efRxCUI 1191138, 1790097, 1790099, 1790100UNII 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

N463323010161 followed by a unit qualifier and the quantity

Package 63323-0101-61. 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 Oct 14, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Doxorubicin Hydrochloride Injection, USP has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms' tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin's disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types. Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-101

What is NDC 63323-101?: 63323-101 is the product NDC for Doxorubicin Hydrochloride, Doxorubicin hydrochloride 2 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, 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?: Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 063277

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

FDA NDC Directory listings under ANDA 063277
Product	Strength	Form · route	Labeler	Product NDC
Doxorubicin Hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-883