Prescription drug · ANDA
azithromycin dihydrate NDC 70436-221
Azithromycin dihydrate 200 mg/5mL · Powder, For suspension · Oral · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-221-34 | 7043602213470436022134 | 1 BOTTLE in 1 CARTON (70436-221-34) / 15 mL in 1 BOTTLEMarketed from Jan 1, 2024 |
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 dihydrate
- Generic name (nonproprietary)
- azithromycin dihydrate
- Active ingredients
- Azithromycin dihydrate — 200 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Slate Run Pharmaceuticals, LLCNDC labeler code 70436
- 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 70436-221_32f66ed6-7a90-559b-e063-6394a90aaf93SPL ID 32f66ed6-7a90-559b-e063-6394a90aaf93SPL set ID 33d4ac05-b564-440c-971d-b78590dd2c32RxCUI 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
N470436022134followed by a unit qualifier and the quantityPackage 70436-0221-34. 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 structur…
Excerpt only. Read the full label for complete information.
About NDC 70436-221
- What is NDC 70436-221?
- 70436-221 is the product NDC for azithromycin dihydrate, Azithromycin dihydrate 200 mg/5mL powder, for suspension, listed with the FDA by Slate Run Pharmaceuticals, 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?
- Slate Run Pharmaceuticals, LLC, NDC labeler code 70436. 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 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 | Azithromycin dihydrate 100 mg/5mL | Powder, For suspensionOral | AiPing Pharmaceutical, Inc. | 11788-128 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | AiPing Pharmaceutical, Inc. | 11788-129 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-8144 |
| 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. | 72673-082 |
| 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 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 | 70436-222 |
| azithromycin dihydrate | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Slate Run Pharmaceuticals, LLC | 70436-228 |