What is NDC 46708-622?

46708-622 is the product NDC for Paclitaxel, Paclitaxel 6 mg/mL injection, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Paclitaxel?

30 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Paclitaxel NDC 46708-622 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-622Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0622Add 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
46708-622-50	46708062250	1 VIAL, MULTI-DOSE in 1 CARTON (46708-622-50) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 20, 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): Paclitaxel
Generic name (nonproprietary): paclitaxel
Active ingredients: Paclitaxel — 6 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216874
Marketing start: Oct 20, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 46708-622_6d04b514-c85c-4db1-919e-21dd98172791SPL ID 6d04b514-c85c-4db1-919e-21dd98172791SPL set ID 6d04b514-c85c-4db1-919e-21dd98172791RxCUI 312199UNII P88XT4IS4D
Pharmacologic class: Microtubule 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

N446708062250 followed by a unit qualifier and the quantity

Package 46708-0622-50. 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 Jan 31, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-622

What is NDC 46708-622?: 46708-622 is the product NDC for Paclitaxel, Paclitaxel 6 mg/mL injection, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Paclitaxel.
What is the active ingredient?: Paclitaxel.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Paclitaxel?: 30 other product NDCs are listed under this name. See all Paclitaxel 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 Paclitaxel NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Paclitaxel	Paclitaxel 6 mg/mL	InjectionIntravenous	BluePoint Laboratories	68001-705	68001-0705-27
Paclitaxel	Paclitaxel 100 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Mylan Institutional LLC	67457-937	67457-0937-50
Paclitaxelpaclitaxel (aibumin-bound)	Paclitaxel 100 mg/100mg	Injection, Powder, Lyophilized, For suspensionIntravenous	Ningbo Shuangcheng Pharmaceutical Co., Ltd	75007-041	—
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Hospira, Inc.	61703-015	61703-0015-04
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Natco Pharma USA LLC	69339-229	69339-0229-50
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Natco Pharma USA LLC	69339-227	69339-0227-05
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Natco Pharma USA LLC	69339-228	69339-0228-17
Paclitaxel	Paclitaxel 100 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Sandoz Inc	0781-3531	00781-3531-91
Paclitaxel	Paclitaxel 100 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Teva Pharmaceuticals, Inc.	0480-3290	00480-3290-01
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-255	25021-0255-0525021-0255-1725021-0255-50

All 31 Paclitaxel NDCs

Other NDCs under ANDA 216874

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

FDA NDC Directory listings under ANDA 216874
Product	Strength	Form · route	Labeler	Product NDC
Paclitaxel	Paclitaxel 6 mg/mL	InjectionIntravenous	BluePoint Laboratories	68001-705
Paclitaxel	Paclitaxel 6 mg/mL	InjectionIntravenous	Alembic Pharmaceuticals Inc.	62332-620
Paclitaxel	Paclitaxel 6 mg/mL	InjectionIntravenous	Alembic Pharmaceuticals Inc.	62332-621
Paclitaxel	Paclitaxel 6 mg/mL	InjectionIntravenous	Alembic Pharmaceuticals Inc.	62332-622
Paclitaxel	Paclitaxel 6 mg/mL	InjectionIntravenous	Alembic Pharmaceuticals Limited	46708-621
Paclitaxel	Paclitaxel 6 mg/mL	InjectionIntravenous	Alembic Pharmaceuticals Limited	46708-620