Prescription drug · NDA
Zithromax (Azithromycin dihydrate) NDC 0069-0400
Azithromycin dihydrate 500 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0400-10 | 0006904001000069040010 | 10 VIAL in 1 CARTON (0069-0400-10) / 5 mL in 1 VIAL (0069-0400-01)Marketed from Mar 7, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Zithromax
- Generic name (nonproprietary)
- azithromycin dihydrate
- Active ingredients
- Azithromycin dihydrate — 500 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050733
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 0069-0400_1e05ce8c-940d-4250-929a-02e7fbc4665fSPL ID 1e05ce8c-940d-4250-929a-02e7fbc4665f
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400069040010followed by a unit qualifier and the quantityPackage 00069-0400-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0069-0400
- What is NDC 0069-0400?
- 0069-0400 is the product NDC for Zithromax (azithromycin dihydrate), Azithromycin dihydrate 500 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, 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?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. 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/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 250 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-0020 | 67296-0020-0167296-0020-02 |
| 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 050733
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 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-3150 |