Prescription drug · ANDA
Azithromycin NDC 63187-007
Azithromycin monohydrate 250 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-007-04 | 63187000704 | 4 TABLET, FILM COATED in 1 BOTTLE (63187-007-04)Marketed from Mar 17, 2022 | |
| 63187-007-06 | 63187000706 | 1 BLISTER PACK in 1 BOX (63187-007-06) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 1, 2014 |
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 monohydrate — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065225
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 63187-007_d6250595-3500-4c6f-8175-25a8a92e2d5eSPL ID d6250595-3500-4c6f-8175-25a8a92e2d5eSPL set ID 7e7c2f49-449c-4ba2-98ae-0ff0c040614cRxCUI 248656, 308460, 749783UNII JTE4MNN1MDUPC 0363187189037, 0363187007041
- 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
N463187000704followed by a unit qualifier and the quantityPackage 63187-0007-04. 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 Azithromycin tablets USP are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations. Adults Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumon…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065225
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 monohydrate 250 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-007 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-006 |
| Azithromycinazithromycin monohydrate | Azithromycin monohydrate 500 mg/1 | Tablet, Film coatedOral | PharmPak, Inc. | 54348-857 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0219 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0784 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 50111-787 |