Prescription drug · ANDA
Azithromycin NDC 50111-787
Azithromycin monohydrate 250 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50111-787-10 | 5011107871050111078710 | 30 TABLET, FILM COATED in 1 BOTTLE (50111-787-10)Marketed from Jan 6, 2006 | |
| 50111-787-51 | 5011107875150111078751 | 1 BLISTER PACK in 1 CARTON (50111-787-51) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 6, 2006 | |
| 50111-787-66 | 5011107876650111078766 | 3 CARTON in 1 PACKAGE (50111-787-66) / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 6, 2006 |
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
- Teva Pharmaceuticals USA, Inc.NDC labeler code 50111
- 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 50111-787_96661456-78d1-48f2-bcd9-ceb3a8437387SPL ID 96661456-78d1-48f2-bcd9-ceb3a8437387SPL set ID f6a52c0b-45db-422e-8c22-e867a11b4439RxCUI 248656, 308460, 749780, 749783UNII JTE4MNN1MDUPC 0350111788107, 0350111787100
- 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
N450111078710followed by a unit qualifier and the quantityPackage 50111-0787-10. 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 tablets are a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 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 and cervicitis in adults ( 1.1 ) Genital ulcer disease in men ( 1.1 ) Acute otitis media in pediatric patients (6 months of age and older) ( 1.2 ) Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1 , 1.2 ) Pharyngitis/tonsillitis in a…
Excerpt only. Read the full label for complete information.
About NDC 50111-787
- What is NDC 50111-787?
- 50111-787 is the product NDC for Azithromycin, Azithromycin monohydrate 250 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, Inc.. 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 monohydrate.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 50111. 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?
- 146 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 | Coupler LLC | 67046-1698 | 67046-1698-03 |
| 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 200 mg/5mL | Powder, For suspensionOral | AiPing Pharmaceutical, Inc. | 11788-129 | 11788-0129-1311788-0129-1411788-0129-15 |
| 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 | A-S Medication Solutions | 50090-8144 | 50090-8144-00 |
| Azithromycinazithromycin monohydrate | Azithromycin monohydrate 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-180 | 25021-0180-10 |
| 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 |
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 |
|---|---|---|---|---|
| Azithromycinazithromycin monohydrate | Azithromycin monohydrate 500 mg/1 | Tablet, Film coatedOral | PharmPak, Inc. | 54348-857 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-007 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0784 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-006 |
| 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 | Sportpharm LLC | 85766-007 |