Prescription drug · ANDA
Azithromycin NDC 46708-057
Azithromycin dihydrate 250 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-057-06 | 46708005706 | 18 BLISTER PACK in 1 CARTON (46708-057-06) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 29, 2020 | |
| 46708-057-18 | 46708005718 | 18 BLISTER PACK in 1 CARTON (46708-057-18) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 29, 2020 | |
| 46708-057-30 | 46708005730 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-057-30)Marketed from Jan 29, 2020 |
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
- Generic name (nonproprietary)
- azithromycin
- Active ingredients
- Azithromycin dihydrate — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211791
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 46708-057_bb31fbb2-b157-4333-ac3b-5f3d65039890SPL ID bb31fbb2-b157-4333-ac3b-5f3d65039890SPL set ID deea1a56-84ed-4ce4-9d11-03271510c0a1RxCUI 308460, 749783UNII 5FD1131I7SUPC 0346708057305
- 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
N446708005706followed by a unit qualifier and the quantityPackage 46708-0057-06. 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 tablets are 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 populations vary in these indications [see Dosage and Administration (2)]. Azithromycin tablets are 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) •…
Excerpt only. Read the full label for complete information.
About NDC 46708-057
- What is NDC 46708-057?
- 46708-057 is the product NDC for Azithromycin, Azithromycin dihydrate 250 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 |
Other NDCs under ANDA 211791
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 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-251 |