Prescription drug · ANDA
azithromycin dihydrate NDC 67046-1503
Azithromycin dihydrate 600 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1503-3 | 6704615030367046150303 | 30 TABLET in 1 BLISTER PACK (67046-1503-3)Marketed from Jan 28, 2025 |
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 — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065400
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 67046-1503_2cc9449e-e4be-3667-e063-6294a90af6baSPL ID 2cc9449e-e4be-3667-e063-6294a90af6baSPL set ID 2cc93e72-95ce-965b-e063-6394a90a8917RxCUI 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
N467046150303followed by a unit qualifier and the quantityPackage 67046-1503-03. 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 indicated for mild to moderate infections caused by designated, susceptible bacteria: Mycobacterial Infections ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.3 ) 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. 1.…
Excerpt only. Read the full label for complete information.
About NDC 67046-1503
- What is NDC 67046-1503?
- 67046-1503 is the product NDC for azithromycin dihydrate, Azithromycin dihydrate 600 mg/1 tablet, listed with the FDA by Coupler LLC. 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?
- Coupler LLC, NDC labeler code 67046. 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 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 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4105 | 70518-4105-0070518-4105-0170518-4105-02 |
Other NDCs under ANDA 065400
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 600 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-863 |