What is NDC 42658-008?

42658-008 is the product NDC for Dactinomycin, Dactinomycin .5 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Hisun Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hisun Pharmaceuticals USA, Inc., NDC labeler code 42658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dactinomycin?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dactinomycin NDC 42658-008 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42658-008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42658-0008Add 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
42658-008-01	4265800080142658000801	1 VIAL in 1 CARTON (42658-008-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from May 8, 2024

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): Dactinomycin
Generic name (nonproprietary): dactinomycin
Active ingredients: Dactinomycin — .5 mg/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Hisun Pharmaceuticals USA, Inc.NDC labeler code 42658
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207232
Marketing start: May 8, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)Protein Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 42658-008_1b25a447-d782-5889-e063-6294a90aebe5SPL ID 1b25a447-d782-5889-e063-6294a90aebe5SPL set ID 95d5c152-aa00-41e6-83e8-8df374a56447RxCUI 239179UNII 1CC1JFE158UPC 0342658008015
Pharmacologic class: Actinomycin

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

N442658000801 followed by a unit qualifier and the quantity

Package 42658-0008-01. 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 May 8, 2024.

Indications (excerpt from the label)

Dactinomycin for injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. ( 1.1 ) adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. ( 1.2 ) adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. ( 1.3 ) adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. ( 1.4 ) post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemothera…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42658-008

What is NDC 42658-008?: 42658-008 is the product NDC for Dactinomycin, Dactinomycin .5 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Hisun Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dactinomycin.
What is the active ingredient?: Dactinomycin.
Who is the labeler?: Hisun Pharmaceuticals USA, Inc., NDC labeler code 42658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dactinomycin?: 4 other product NDCs are listed under this name. See all Dactinomycin 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 Dactinomycin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dactinomycin	Dactinomycin .5 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-431	55150-0431-01
Dactinomycin	Dactinomycin .5 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-928	55150-0928-02
Dactinomycin	Dactinomycin .5 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-129	71288-0129-02
dactinomycin	Dactinomycin .5 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	XGen Pharmaceuticals DJB, Inc.	39822-2100	39822-2100-02