Prescription drug · ANDA
Azithromycin NDC 67296-2141
Azithromycin dihydrate 200 mg/5mL · Powder, For suspension · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2141-1 | 67296214101 | 1 BOTTLE in 1 CARTON (67296-2141-1) / 15 mL in 1 BOTTLEMarketed from Aug 6, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- azithromycin
- Active ingredients
- Azithromycin dihydrate — 200 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Redpharm Drug
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211147
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 67296-2141_46aca6ab-7486-ab8c-e063-6394a90a3aa6SPL ID 46aca6ab-7486-ab8c-e063-6394a90a3aa6SPL set ID 3745a0b0-7855-69eb-e063-6294a90ab6a8RxCUI 141963UNII 5FD1131I7S
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N467296214101followed by a unit qualifier and the quantityPackage 67296-2141-01. 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 is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration ( 2 )] Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1 ) Acute bacterial sinusitis in adults ( 1.1 ) Uncomplicated skin and skin structure infections in adults ( 1.1) Urethritis…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211147
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 |
|---|---|---|---|---|
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-4458 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8246 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4779 |
| Azithromycin | Azithromycin dihydrate 100 mg/5mL | Powder, For suspensionOral | Zydus Pharmaceuticals USA Inc. | 70710-1457 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Pharmaceuticals USA Inc. | 70710-1460 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Pharmaceuticals USA Inc. | 70710-1458 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Pharmaceuticals USA Inc. | 70710-1459 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Lifesciences Limited | 70771-1423 |
| Azithromycin | Azithromycin dihydrate 100 mg/5mL | Powder, For suspensionOral | Zydus Lifesciences Limited | 70771-1422 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Lifesciences Limited | 70771-1424 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Lifesciences Limited | 70771-1425 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-216 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6267 |