NDC codes

FDA NDC Directory
Product NDC (as listed)43598-610Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0610Add 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 NDC11-digit (billing)PackageCopy
43598-610-40435980610404 mL in 1 VIAL, GLASS (43598-610-40)Marketed from Aug 22, 2017

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 — 80 mg/4mL
Dosage form
Injection, Solution
Route
Intravenous
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204193
Marketing start
Listing expires
Other FDA classes
Microtubule Inhibition (Physiologic effect)
Identifiers
Product ID 43598-610_948f7c4c-6a40-d240-3eb3-d9ae6e371429SPL ID 948f7c4c-6a40-d240-3eb3-d9ae6e371429SPL set ID be3df07d-ea56-453a-25ad-c3cedc22712aRxCUI 1860480, 1860485UNII 15H5577CQD
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

N443598061040 followed by a unit qualifier and the quantity

Package 43598-0610-40. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 204193

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

FDA NDC Directory listings under ANDA 204193
ProductStrengthForm · routeLabelerProduct NDC
DocetaxelDocetaxel 20 mg/mLInjection, SolutionIntravenousDr. Reddy's Laboratories Inc.43598-258
DocetaxelDocetaxel 80 mg/4mLInjection, SolutionIntravenousDr. Reddy's Laboratories Inc.43598-259
DocetaxelDocetaxel 160 mg/8mLInjection, SolutionIntravenousDr. Reddy's Laboratories Inc.43598-389
DocetaxelDocetaxel 20 mg/mLInjection, SolutionIntravenousDr. Reddy's Laboratories Inc.43598-611

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