What is NDC 0409-3510?

0409-3510 is the product NDC for Ertapenem, Ertapenem sodium 1 g/1 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.

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 Ertapenem?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ertapenem NDC 0409-3510 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0409-3510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00409-3510Add 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
0409-3510-22	0040935102200409351022	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3510-22) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-3510-21)Marketed from Oct 19, 2020

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): Ertapenem
Generic name (nonproprietary): ertapenem
Active ingredients: Ertapenem sodium — 1 g/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intramuscular, Intravenous
Labeler: Hospira, Inc.NDC labeler code 0409
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208790
Marketing start: Oct 19, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Carbapenems (Chemical structure)
Identifiers: Product ID 0409-3510_7dea65ba-ff7e-445b-972e-c972c3140d91SPL ID 7dea65ba-ff7e-445b-972e-c972c3140d91SPL set ID 178a0356-4f6c-47fb-9913-f325a3c72f7bRxCUI 1734683UNII 2T90KE67L0
Pharmacologic class: Penem 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

N400409351022 followed by a unit qualifier and the quantity

Package 00409-3510-22. 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 Nov 6, 2024.

Indications (excerpt from the label)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for Injection and other antibacterial drugs, Ertapenem for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment Ertapenem for Injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the fo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0409-3510

What is NDC 0409-3510?: 0409-3510 is the product NDC for Ertapenem, Ertapenem sodium 1 g/1 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?: Ertapenem.
What is the active ingredient?: Ertapenem sodium.
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 Ertapenem?: 13 other product NDCs are listed under this name. See all Ertapenem 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 Ertapenem NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ertapenemertapenem sodium	Ertapenem sodium 1 g/20mL	InjectionIntramuscular, Intravenous	Apotex Corp	60505-4956	60505-4956-00
Ertapenemertapenem sodium	Ertapenem sodium 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-199	25021-0199-20
Ertapenemertapenem sodium	Ertapenem sodium 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0143-9429	00143-9429-10
Ertapenemertapenem sodium	Ertapenem sodium 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Qilu Antibiotics Pharmaceutical Co., Ltd.	51810-504	51810-0504-02
Ertapenemertapenem sodium	Ertapenem sodium 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Fosun Pharma USA Inc	72266-159	72266-0159-0572266-0159-10
Ertapenemertapenem sodium	Ertapenem sodium 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Gland Pharma Limited	68083-351	68083-0351-10
ertapenem	Ertapenem sodium 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	WG Critical Care, LLC	44567-820	44567-0820-10
Ertapenemertapenem sodium	Ertapenem sodium 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-823	63323-0823-20
Ertapenemertapenem sodium	Ertapenem sodium 1 g/20mL	InjectionIntramuscular, Intravenous	BluePoint Laboratories	68001-408	68001-0408-31
Ertapenemertapenem sodium	Ertapenem sodium 1 g/20mL	InjectionIntramuscular, Intravenous	Apotex Corp	60505-6196	60505-6196-04

All 14 Ertapenem NDCs

Other NDCs under ANDA 208790

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

FDA NDC Directory listings under ANDA 208790
Product	Strength	Form · route	Labeler	Product NDC
ertapenem	Ertapenem sodium 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	WG Critical Care, LLC	44567-820
Ertapenemertapenem sodium	Ertapenem sodium 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-823
ertapenem sodium	Ertapenem sodium 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Hikma Pharmaceuticals USA, Inc.	0143-9398