Prescription drug · ANDA
Azithromycin Dihydrate NDC 50090-4527
Azithromycin dihydrate 250 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4527-0 | 5009045270050090452700 | 4 TABLET, FILM COATED in 1 BOTTLE (50090-4527-0)Marketed from Sep 16, 2019 |
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 Dihydrate
- Generic name (nonproprietary)
- azithromycin dihydrate
- Active ingredients
- Azithromycin dihydrate — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208250
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 50090-4527_73b54c1b-428f-40d2-b27e-79401310690eSPL ID 73b54c1b-428f-40d2-b27e-79401310690eSPL set ID 1c84a68b-3eaa-4dab-b5e5-e195c7652e67RxCUI 308460UNII 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
N450090452700followed by a unit qualifier and the quantityPackage 50090-4527-00. 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.
About NDC 50090-4527
- What is NDC 50090-4527?
- 50090-4527 is the product NDC for Azithromycin Dihydrate, Azithromycin dihydrate 250 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azithromycin Dihydrate.
- What is the active ingredient?
- Azithromycin dihydrate.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 Dihydrate?
- 42 other product NDCs are listed under this name. See all Azithromycin Dihydrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Azithromycin Dihydrate 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 Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1607 | 67046-1607-03 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1502 | 67046-1502-03 |
| azithromycin dihydrate | Azithromycin dihydrate 600 mg/1 | TabletOral | Coupler LLC | 67046-1503 | 67046-1503-03 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8800 | 68788-8800-06 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8773 | 68788-8773-0368788-8773-04 |
| Azithromycin Dihydrate | Azithromycin dihydrate 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4202 | 70518-4202-00 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Quality Care Products, LLC | 83008-081 | 83008-0081-06 |
| azithromycin dihydrate | Azithromycin dihydrate 250 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0431 | 80425-0431-01 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4160 | 70518-4160-0070518-4160-0170518-4160-02+3 more |
| azithromycin dihydrate | Azithromycin dihydrate 500 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0412 | 80425-0412-01 |
Other NDCs under ANDA 208250
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 Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4601 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-074 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | TAGI Pharma, Inc. | 51224-022 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1502 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2185 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals Inc. | 68071-3715 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Precision Dose, Inc. | 68094-900 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8800 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4160 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-430 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-089 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-081 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-483 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-046 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0218 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-182 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Quality Care Products, LLC | 83008-081 |