NDC codes

FDA NDC Directory
Product NDC (as listed)0409-0122Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00409-0122Add 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
0409-0122-0100409012201004090122011 VIAL, SINGLE-DOSE in 1 CARTON (0409-0122-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 2, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Hospira, Inc.NDC labeler code 0409
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 210282
Marketing start
Listing expires
Other FDA classes
Lipopeptides (Chemical structure)
Identifiers
Product ID 0409-0122_70737bda-cf0c-42f1-89bc-d47e321d2218SPL ID 70737bda-cf0c-42f1-89bc-d47e321d2218SPL set ID 1957b6ce-7382-4a7b-bf02-3595948d09c6RxCUI 403920, 1996246UNII 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

N400409012201 followed by a unit qualifier and the quantity

Package 00409-0122-01. 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 .

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 patients ( 1.1 ) and, • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, ( 1.2 ) Limitations of Use: • This Daptomycin for Injection product is not approved for use in pediatric patients. ( 1.3 ) • Daptomycin for Injection is not indicated for the treatment of pneumonia. ( 1.3 ) • Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus . ( 1.3 ) • Daptomycin for Injection is not recommended in pediat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0409-0122

What is NDC 0409-0122?
0409-0122 is the product NDC for Daptomycin, Daptomycin 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Hospira, Inc.. 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?
Hospira, Inc., NDC labeler code 0409. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DaptomycinDaptomycin 350 mg/7mLInjection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-945500143-9455-01
DaptomycinDaptomycin 500 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-944500143-9445-01
DaptomycinDaptomycin 350 mg/7mLInjection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-945600143-9456-01
DaptomycinDaptomycin 500 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousCivica, Inc.72572-15872572-0158-01
DaptomycinDaptomycin 500 mg/1Injection, Powder, Lyophilized, For solutionIntravenousPar Health USA, LLC42023-29542023-0295-10
DaptomycinDaptomycin 500 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-944400143-9444-01
DaptomycinDaptomycin 500 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-946500143-9465-01
DaptomycinDaptomycin 500 mg/1Injection, Powder, Lyophilized, For solutionIntravenousMAIA Pharmaceuticals, Inc.70511-18270511-0182-84
DaptomycinDaptomycin 500 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousBiocon Pharma Inc.70377-09370377-0093-91
daptomycinDaptomycin 500 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousMylan Institutional LLC67457-94167457-0941-15

All 42 Daptomycin NDCs

Other NDCs under NDA 210282

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

FDA NDC Directory listings under NDA 210282
ProductStrengthForm · routeLabelerProduct NDC
DaptomycinDaptomycin 350 mg/7mLInjection, Powder, Lyophilized, For solutionIntravenousHospira, Inc.0409-0120

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