Prescription drug · ANDA
Azithromycin NDC 0781-8091
Azithromycin dihydrate 600 mg/1 · Tablet, Film coated · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-8091-31 | 00781809131 | 30 TABLET, FILM COATED in 1 BOTTLE (0781-8091-31)Marketed from Feb 14, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Generic name (nonproprietary)
- azithromycin
- Active ingredients
- Azithromycin dihydrate — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065209
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 0781-8091_2c6bb78a-a9da-43e0-9a72-b8723229e1b7SPL ID 2c6bb78a-a9da-43e0-9a72-b8723229e1b7SPL set ID 34b70c23-92a6-460f-8dbb-15a0e6b9d3a9RxCUI 204844UNII 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
N400781809131followed by a unit qualifier and the quantityPackage 00781-8091-31. 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 indicated for the treatment of adult patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: • Sexually Transmitted Diseases ( 1.1 ) • Mycobacterial Infections ( 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 Sexually Transmitted Diseases Azithromycin tablets are indicated for the treatment of adult patients with mild to mod…
Excerpt only. Read the full label for complete information.
About NDC 0781-8091
- What is NDC 0781-8091?
- 0781-8091 is the product NDC for Azithromycin, Azithromycin dihydrate 600 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azithromycin.
- What is the active ingredient?
- Azithromycin dihydrate.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. 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?
- 139 other product NDCs are listed under this name. See all Azithromycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Azithromycin 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 | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-726 | 64980-0726-0364980-0726-13 |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-727 | 64980-0727-0364980-0727-16 |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0508 | 67046-0508-03 |
| Azithromycin | Azithromycin dihydrate 100 mg/5mL | Powder, For suspensionOral | AiPing Pharmaceutical, Inc. | 11788-128 | 11788-0128-13 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | AiPing Pharmaceutical, Inc. | 11788-129 | 11788-0129-1311788-0129-1411788-0129-15 |
| azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4367 | 70518-4367-0070518-4367-0170518-4367-03+1 more |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4356 | 70518-4356-00 |
| Azithromycin | Azithromycin monohydrate 200 mg/5mL | Powder, For suspensionOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-707 | 24658-0707-33 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-081 | 72673-0081-60 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-082 | 72673-0082-90 |