Prescription drug · ANDA
Azithromycin monohydrate NDC 68083-199
Azithromycin monohydrate 500 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-199-10 | 6808301991068083019910 | 10 VIAL in 1 CARTON (68083-199-10) / 10 mL in 1 VIALMarketed from Nov 9, 2009 |
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)
- Azithromycin monohydrate
- Generic name (nonproprietary)
- azithromycin monohydrate
- Active ingredients
- Azithromycin monohydrate — 500 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065501
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 68083-199_87bbc473-3fe8-475b-bf73-2e101377977aSPL ID 87bbc473-3fe8-475b-bf73-2e101377977aSPL set ID 55051e03-b6dc-4bc6-87c1-e4fb84b61fa3RxCUI 1668238UNII JTE4MNN1MDUPC 0368083199104
- Pharmacologic class
- Macrolide Antimicrobial
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
N468083019910followed by a unit qualifier and the quantityPackage 68083-0199-10. 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 .
Indications (excerpt from the label)
Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms: • Community-acquired pneumonia in adults ( 1.1 ) • Pelvic inflammatory disease in adults ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.3 ) 1.1 Community-Acquired Pneumonia Azithromycin for injection is indicated for the treatment of adult patients with community-acquired pneumonia due to the foll…
Excerpt only. Read the full label for complete information.
About NDC 68083-199
- What is NDC 68083-199?
- 68083-199 is the product NDC for Azithromycin monohydrate, Azithromycin monohydrate 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azithromycin monohydrate.
- What is the active ingredient?
- Azithromycin monohydrate.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Azithromycin monohydrate?
- 1 other product NDC are listed under this name. See all Azithromycin monohydrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Azithromycin monohydrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Azithromycin monohydrate | Azithromycin monohydrate 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sun Pharmaceutical Industries, Inc. | 70095-025 | 70095-0025-02 |
Other NDCs under ANDA 065501
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 |
|---|---|---|---|---|
| Azithromycinazithromycin monohydrate | Azithromycin monohydrate 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-180 |
| Azithromycinazithromycin monohydrate | Azithromycin monohydrate 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Athenex Pharmaceutical Division, LLC. | 70860-100 |
| Azithromycinazithromycin monohydrate | Azithromycin monohydrate 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Athenex Pharmaceutical Division, LLC. | 70860-125 |
| Azithromycin monohydrate | Azithromycin monohydrate 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sun Pharmaceutical Industries, Inc. | 70095-025 |