Prescription drug · ANDA
Azithromycin NDC 11788-129
Azithromycin dihydrate 200 mg/5mL · Powder, For suspension · Oral · AiPing Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11788-129-13 | 11788012913 | 1 BOTTLE in 1 CARTON (11788-129-13) / 15 mL in 1 BOTTLEMarketed from Jan 16, 2026 | |
| 11788-129-14 | 11788012914 | 1 BOTTLE in 1 CARTON (11788-129-14) / 22.5 mL in 1 BOTTLEMarketed from Jan 16, 2026 | |
| 11788-129-15 | 11788012915 | 1 BOTTLE in 1 CARTON (11788-129-15) / 30 mL in 1 BOTTLEMarketed from Jan 16, 2026 |
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 dihydrate — 200 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- AiPing Pharmaceutical, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217036
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 11788-129_b4d8ea81-97cd-4aeb-a1a9-48e3f8587356SPL ID b4d8ea81-97cd-4aeb-a1a9-48e3f8587356SPL set ID d6fb42ed-7dac-4a7b-9964-d367dd47dd5cRxCUI 141963, 308459UNII 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
N411788012913followed by a unit qualifier and the quantityPackage 11788-0129-13. 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 for oral suspension 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 for oral suspension 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217036
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 100 mg/5mL | Powder, For suspensionOral | Slate Run Pharmaceuticals, LLC | 70436-220 |
| azithromycin dihydrate | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Slate Run Pharmaceuticals, LLC | 70436-228 |
| azithromycin dihydrate | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Slate Run Pharmaceuticals, LLC | 70436-221 |
| azithromycin dihydrate | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Slate Run Pharmaceuticals, LLC | 70436-222 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-082 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-081 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-083 |
| Azithromycin | Azithromycin dihydrate 100 mg/5mL | Powder, For suspensionOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-084 |
| Azithromycin | Azithromycin dihydrate 100 mg/5mL | Powder, For suspensionOral | AiPing Pharmaceutical, Inc. | 11788-128 |