Ertapenem (ertapenem sodium) NDC 44647-051

NDC codes

FDA NDC Directory

Product NDC (as listed)44647-051Labeler and product segments. Claims need a package NDC.

Product NDC at billing width44647-0051Add 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
44647-051-10	44647005110	10 VIAL in 1 CARTON (44647-051-10) / 20 mL in 1 VIAL (44647-051-01)Marketed from Mar 19, 2019

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): Ertapenem
Generic name (nonproprietary): ertapenem sodium
Active ingredients: Ertapenem sodium — 1 g/20mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Savior Lifetec Corporation
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207647
Marketing start: Mar 19, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Carbapenems (Chemical structure)
Identifiers: Product ID 44647-051_0b211a36-8d30-fb5e-e063-6294a90af3deSPL ID 0b211a36-8d30-fb5e-e063-6294a90af3deSPL set ID c4da28cb-6725-4fa1-a7b0-e84f408fb36bRxCUI 1734683UNII 2T90KE67L0UPC 0344647051019, 0344647051101
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

N444647005110 followed by a unit qualifier and the quantity

Package 44647-0051-10. 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 27, 2023.

Indications (excerpt from the label)

Ertapenem for injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. ( 1.1 ) Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. ( 1.2 ) Community-acquired pneumonia. ( 1.3 ) Complicated urinary tract infections including pyelonephritis. ( 1.4 ) Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. ( 1.5 ) Ertapenem for injection is indicated in adults for the prophylaxis of surgic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207647

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

FDA NDC Directory listings under ANDA 207647
Product	Strength	Form · route	Labeler	Product NDC
Ertapenemertapenem sodium	Ertapenem sodium 1 g/20mL	InjectionIntramuscular, Intravenous	BluePoint Laboratories	68001-408
Ertapenemertapenem sodium	Ertapenem sodium 1 g/20mL	InjectionIntramuscular, Intravenous	Apotex Corp	60505-6196