What is NDC 70594-034?

70594-034 is the product NDC for Daptomycin, Daptomycin 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Xellia Pharmaceuticals USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Xellia Pharmaceuticals USA LLC, NDC labeler code 70594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Daptomycin?

41 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Daptomycin NDC 70594-034 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70594-034Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70594-0034Add 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
70594-034-02	7059400340270594003402	1 VIAL, SINGLE-USE in 1 CARTON (70594-034-02) / 10 mL in 1 VIAL, SINGLE-USEMarketed from May 1, 2021

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): Daptomycin
Generic name (nonproprietary): daptomycin
Active ingredients: Daptomycin — 500 mg/10mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Xellia Pharmaceuticals USA LLCNDC labeler code 70594
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206005
Marketing start: May 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Lipopeptides (Chemical structure)
Identifiers: Product ID 70594-034_f40b0e0b-bbc7-4ac6-b98b-b55e6734fd92SPL ID f40b0e0b-bbc7-4ac6-b98b-b55e6734fd92SPL set ID fc7eef03-042b-44a1-a344-1fa8a0435900RxCUI 403920UNII NWQ5N31VKK
Pharmacologic class: Lipopeptide Antibacterial

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

N470594003402 followed by a unit qualifier and the quantity

Package 70594-0034-02. 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 Aug 4, 2023.

Indications (excerpt from the label)

Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1 ) and, Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, ( 1.2 ) Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). ( 1.3 ) Limitations of Use: Daptomycin for injection is not indicated for the treatment of pneumonia. ( 1.4 ) Daptomycin for injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus . ( 1.4 ) Daptomyci…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70594-034

What is NDC 70594-034?: 70594-034 is the product NDC for Daptomycin, Daptomycin 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Xellia Pharmaceuticals USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Daptomycin.
What is the active ingredient?: Daptomycin.
Who is the labeler?: Xellia Pharmaceuticals USA LLC, NDC labeler code 70594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Daptomycin?: 41 other product NDCs are listed under this name. See all Daptomycin 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 Daptomycin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Daptomycin	Daptomycin 350 mg/7mL	Injection, Powder, Lyophilized, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9455	00143-9455-01
Daptomycin	Daptomycin 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9445	00143-9445-01
Daptomycin	Daptomycin 350 mg/7mL	Injection, Powder, Lyophilized, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9456	00143-9456-01
Daptomycin	Daptomycin 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Civica, Inc.	72572-158	72572-0158-01
Daptomycin	Daptomycin 500 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Par Health USA, LLC	42023-295	42023-0295-10
Daptomycin	Daptomycin 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9444	00143-9444-01
Daptomycin	Daptomycin 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9465	00143-9465-01
Daptomycin	Daptomycin 500 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	MAIA Pharmaceuticals, Inc.	70511-182	70511-0182-84
Daptomycin	Daptomycin 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Biocon Pharma Inc.	70377-093	70377-0093-91
daptomycin	Daptomycin 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Mylan Institutional LLC	67457-941	67457-0941-15

All 42 Daptomycin NDCs

Other NDCs under ANDA 206005

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

FDA NDC Directory listings under ANDA 206005
Product	Strength	Form · route	Labeler	Product NDC
Daptomycin	Daptomycin 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9444
Daptomycin	Daptomycin 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9465
Daptomycin	Daptomycin 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Civica, Inc.	72572-102