NDC codes

FDA NDC Directory
Product NDC (as listed)16714-889Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0889Add 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
16714-889-101671408891010 VIAL, SINGLE-DOSE in 1 CARTON (16714-889-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (16714-889-01)Marketed from Jul 13, 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)
Ertapenem Sodium
Generic name (nonproprietary)
ertapenem
Active ingredients
Ertapenem sodium — 1 g/1
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intramuscular, Intravenous
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212040
Marketing start
Listing expires
Other FDA classes
Carbapenems (Chemical structure)
Identifiers
Product ID 16714-889_b1a0c90d-c014-6561-5ab3-07e98e9fdfeaSPL ID b1a0c90d-c014-6561-5ab3-07e98e9fdfeaSPL set ID 2398d418-6efc-b4d2-3265-936001df9b8bRxCUI 1734683UNII 2T90KE67L0UPC 0316714889016
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

N416714088910 followed by a unit qualifier and the quantity

Package 16714-0889-10. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 212040

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

FDA NDC Directory listings under ANDA 212040
ProductStrengthForm · routeLabelerProduct NDC
Ertapenem SodiumertapenemErtapenem sodium 1 g/1Injection, Powder, Lyophilized, For solutionIntramuscular, IntravenousDr.Reddys Laboratories Inc.,43598-901
Ertapenemertapenem sodiumErtapenem sodium 1 g/1Injection, Powder, Lyophilized, For solutionIntramuscular, IntravenousGland Pharma Limited68083-351
Ertapenemertapenem sodiumErtapenem sodium 1 g/1Injection, Powder, Lyophilized, For solutionIntramuscular, IntravenousFosun Pharma USA Inc72266-159

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