Prescription drug · NDA
Zithromax (Azithromycin dihydrate) NDC 67296-0020
Azithromycin dihydrate 250 mg/1 · Tablet, Film coated · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-0020-1 | 6729600200167296002001 | 4 TABLET, FILM COATED in 1 BOTTLE (67296-0020-1)Marketed from Jul 18, 1996 | |
| 67296-0020-2 | 6729600200267296002002 | 6 TABLET, FILM COATED in 1 BOTTLE (67296-0020-2)Marketed from Jul 18, 1996 |
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)
- Zithromax
- Generic name (nonproprietary)
- azithromycin dihydrate
- Active ingredients
- Azithromycin dihydrate — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Redpharm DrugNDC labeler code 67296
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050711
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 67296-0020_3ddecd2f-ea4c-536f-e063-6294a90a7936SPL ID 3ddecd2f-ea4c-536f-e063-6294a90a7936SPL set ID 3ddecd25-dc32-a2af-e063-6294a90a526dRxCUI 212446, 308460UNII 5FD1131I7SUPC 0300693060306, 0300693070305
- 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
N467296002001followed by a unit qualifier and the quantityPackage 67296-0020-01. 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)
ZITHROMAX (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) ] ZITHROMAX 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 ) U…
Excerpt only. Read the full label for complete information.
About NDC 67296-0020
- What is NDC 67296-0020?
- 67296-0020 is the product NDC for Zithromax (azithromycin dihydrate), Azithromycin dihydrate 250 mg/1 tablet, film coated, listed with the FDA by Redpharm Drug. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zithromax (Azithromycin dihydrate).
- What is the active ingredient?
- Azithromycin dihydrate.
- Who is the labeler?
- Redpharm Drug, NDC labeler code 67296. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zithromax?
- 8 other product NDCs are listed under this name. See all Zithromax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zithromax products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zithromaxazithromycin dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-4061 | 00069-4061-01 |
| Zithromaxazithromycin dihydrate | Azithromycin dihydrate 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-0400 | 00069-0400-10 |
| Zithromaxazithromycin dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-3070 | 00069-3070-3000069-3070-75 |
| Zithromaxazithromycin dihydrate | Azithromycin dihydrate 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-3150 | 00069-3150-83 |
| Zithromaxazithromycin dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-3060 | 00069-3060-75 |
| Zithromaxazithromycin dihydrate | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Pfizer Laboratories Div Pfizer Inc | 0069-3120 | 00069-3120-19 |
| Zithromaxazithromycin dihydrate | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Pfizer Laboratories Div Pfizer Inc | 0069-3130 | 00069-3130-19 |
| Zithromaxazithromycin dihydrate | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Pfizer Laboratories Div Pfizer Inc | 0069-3140 | 00069-3140-19 |
Other NDCs under NDA 050711
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 |
|---|---|---|---|---|
| Zithromaxazithromycin dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-3060 |
| Zithromaxazithromycin dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-4061 |