What is NDC 47335-895?

47335-895 is the product NDC for Docetaxel, Docetaxel anhydrous 80 mg/4mL injection, solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Docetaxel?

61 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Docetaxel NDC 47335-895 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-895Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0895Add 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
47335-895-40	47335089540	1 VIAL, GLASS in 1 CARTON (47335-895-40) / 4 mL in 1 VIAL, GLASSMarketed from Nov 26, 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): Docetaxel
Generic name (nonproprietary): docetaxel
Active ingredients: Docetaxel anhydrous — 80 mg/4mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022534
Marketing start: Nov 26, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 47335-895_9a0d7b91-4324-4e19-9cd8-eb19266e771aSPL ID 9a0d7b91-4324-4e19-9cd8-eb19266e771aSPL set ID c85b2c62-3c33-4cbc-8b79-d5e17851a1b4RxCUI 1860480, 1860485, 1861411UNII 699121PHCA
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

N447335089540 followed by a unit qualifier and the quantity

Package 47335-0895-40. 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 Feb 4, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

DOCETAXEL INJECTION is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1) Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2) Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3) Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-895

What is NDC 47335-895?: 47335-895 is the product NDC for Docetaxel, Docetaxel anhydrous 80 mg/4mL injection, solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Docetaxel.
What is the active ingredient?: Docetaxel anhydrous.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Docetaxel?: 61 other product NDCs are listed under this name. See all Docetaxel 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 Docetaxel NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Docetaxel	Docetaxel anhydrous 10 mg/mL	InjectionIntravenous	Baxter Healthcare Corporation	43066-046	43066-0046-08
Docetaxel	Docetaxel anhydrous 10 mg/mL	InjectionIntravenous	Baxter Healthcare Corporation	43066-044	43066-0044-02
Docetaxel	Docetaxel anhydrous 10 mg/mL	InjectionIntravenous	Baxter Healthcare Corporation	43066-048	43066-0048-16
Docetaxel	Docetaxel 20 mg/mL	Injection, Solution, ConcentrateIntravenous	Meitheal Pharmaceuticals Inc.	71288-133	71288-0133-01
Docetaxel	Docetaxel 20 mg/mL	Injection, Solution, ConcentrateIntravenous	Meitheal Pharmaceuticals Inc.	71288-152	71288-0152-04
Docetaxel	Docetaxel 160 mg/8mL	InjectionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-905	23155-0905-31
Docetaxel	Docetaxel 20 mg/mL	InjectionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-903	23155-0903-31
Docetaxel	Docetaxel 80 mg/4mL	InjectionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-904	23155-0904-31
Docetaxeldocetaxel anhydrous	Docetaxel anhydrous 10 mg/mL	InjectionIntravenous	Sagent Pharmaceuticals	25021-254	25021-0254-0825021-0254-16
Docetaxel	Docetaxel anhydrous 10 mg/mL	InjectionIntravenous	Alembic Pharmaceuticals Limited	46708-678	46708-0678-0246708-0678-0846708-0678-16

All 62 Docetaxel NDCs

Other NDCs under NDA 022534

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

FDA NDC Directory listings under NDA 022534
Product	Strength	Form · route	Labeler	Product NDC
Docetaxel	Docetaxel anhydrous 20 mg/mL	Injection, SolutionIntravenous	Sun Pharmaceutical Industries, Inc.	47335-323
Docetaxel	Docetaxel anhydrous 160 mg/8mL	Injection, SolutionIntravenous	Sun Pharmaceutical Industries, Inc.	47335-939