erythromycin lactobionate NDC 68083-513

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-513Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0513Add 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
68083-513-10	68083051310	10 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01)Marketed from Nov 19, 2024

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): erythromycin lactobionate
Generic name (nonproprietary): erythromycin lactobionate
Active ingredients: Erythromycin lactobionate — 500 mg/10mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216761
Marketing start: Nov 19, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
Identifiers: Product ID 68083-513_62d03a60-5432-4fa9-a4bb-e14276b78b47SPL ID 62d03a60-5432-4fa9-a4bb-e14276b78b47SPL set ID c6f9565b-6d9d-40e3-87f8-9f38ede9173aRxCUI 1668264UNII 33H58I7GLQUPC 0368083513016
Pharmacologic class: Macrolide Antimicrobial; Macrolide

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

N468083051310 followed by a unit qualifier and the quantity

Package 68083-0513-10. 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 216761

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

FDA NDC Directory listings under ANDA 216761
Product	Strength	Form · route	Labeler	Product NDC
Erythromycin Lactobionate	Erythromycin lactobionate 500 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Armas Pharmaceuticals Inc.	72485-701
Erythromycin Lactobionate	Erythromycin lactobionate 500 mg/1	Injection, Powder, For solutionIntravenous	Piramal Critical Care Inc.	66794-251