What is NDC 83090-011?

83090-011 is the product NDC for daptomycin, Daptomycin 500 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by Sintetica US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Sintetica US LLC, NDC labeler code 83090. 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 83090-011 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83090-011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83090-0011Add 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
83090-011-01	8309000110183090001101	1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 5, 2023

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/20mL
Dosage form: Injection, Powder, Lyophilized, For suspension
Route: Intravenous
Labeler: Sintetica US LLCNDC labeler code 83090
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215890
Marketing start: Nov 5, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Lipopeptides (Chemical structure)
Identifiers: Product ID 83090-011_5ef48d1a-eecc-4782-b347-7930a733e603SPL ID 5ef48d1a-eecc-4782-b347-7930a733e603SPL set ID 0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e3RxCUI 403920UNII NWQ5N31VKKUPC 0383090011010
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

N483090001101 followed by a unit qualifier and the quantity

Package 83090-0011-01. 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 Feb 7, 2025.

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 83090-011

What is NDC 83090-011?: 83090-011 is the product NDC for daptomycin, Daptomycin 500 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by Sintetica US 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?: Sintetica US LLC, NDC labeler code 83090. 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 215890

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

FDA NDC Directory listings under ANDA 215890
Product	Strength	Form · route	Labeler	Product NDC
daptomycin	Daptomycin 500 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Hainan Poly Pharm., Co., Ltd.	14335-120
daptomycin	Daptomycin 500 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Slate Run Pharmaceuticals, LLC	70436-033