Prescription drug · ANDA
Erythromycin Lactobionate NDC 66794-251
Erythromycin lactobionate 500 mg/1 · Injection, Powder, For solution · Intravenous · Piramal Critical Care Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66794-251-41 | 6679402514166794025141 | 10 VIAL in 1 CARTON (66794-251-41) / 500 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-251-02)Marketed from Aug 13, 2026 |
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/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Piramal Critical Care Inc.NDC labeler code 66794
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216761
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 66794-251_593675b3-e44e-0b1e-e063-6294a90a3ee7SPL ID 593675b3-e44e-0b1e-e063-6294a90a3ee7SPL set ID ee345752-0f0c-c69b-e053-2995a90a7dacRxCUI 1668264UNII 33H58I7GLQUPC 0366794251029
- 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.
- NDC on a medical claim
N466794025141followed by a unit qualifier and the quantityPackage 66794-0251-41. 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)
INDICATIONS AND USAGE Erythromycin lactobionate for injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Intravenous therapy should be replaced by oral administration at the appropriate time. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae); Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many s…
Excerpt only. Read the full label for complete information.
About NDC 66794-251
- What is NDC 66794-251?
- 66794-251 is the product NDC for Erythromycin Lactobionate, Erythromycin lactobionate 500 mg/1 injection, powder, for solution, listed with the FDA by Piramal Critical Care Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Erythromycin Lactobionate.
- What is the active ingredient?
- Erythromycin lactobionate.
- Who is the labeler?
- Piramal Critical Care Inc., NDC labeler code 66794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Erythromycin Lactobionate?
- 2 other product NDCs are listed under this name. See all Erythromycin Lactobionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Erythromycin Lactobionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Erythromycin Lactobionate | Erythromycin lactobionate 500 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Armas Pharmaceuticals Inc. | 72485-701 | 72485-0701-10 |
| erythromycin lactobionate | Erythromycin lactobionate 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-513 | 68083-0513-10 |
Other NDCs under ANDA 216761
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| erythromycin lactobionate | Erythromycin lactobionate 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-513 |
| Erythromycin Lactobionate | Erythromycin lactobionate 500 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Armas Pharmaceuticals Inc. | 72485-701 |