Prescription drug · ANDA
Oseltamivir Phosphate NDC 68180-678
Oseltamivir phosphate 6 mg/mL · Powder, For suspension · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-678-01 | 6818006780168180067801 | 1 BOTTLE, GLASS in 1 CARTON (68180-678-01) / 60 mL in 1 BOTTLE, GLASSMarketed from Feb 21, 2018 |
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)
- Oseltamivir Phosphate
- Generic name (nonproprietary)
- oseltamivir phosphate
- Active ingredients
- Oseltamivir phosphate — 6 mg/mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208347
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 68180-678_7916db0e-271a-45a3-be4f-5ab7838a3127SPL ID 7916db0e-271a-45a3-be4f-5ab7838a3127SPL set ID b428e1f2-0082-4d9f-908e-e3633ea0457bRxCUI 1115698UNII 4A3O49NGEZ
- Pharmacologic class
- Neuraminidase Inhibitor
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
N468180067801followed by a unit qualifier and the quantityPackage 68180-0678-01. 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)
Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. ( 1.1 ) Prophylaxis of influenza A and B in patients 1 year and older. ( 1.2 ) Limitations of Use: Not a substitute for annual influenza vaccination. ( 1.3 ) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. ( 1.3 ) Not recommended for patients with end-stage renal disease not undergoing dialysis. ( 1.3 ) 1.1 Treatment of Influenza Oseltamivir phosphate for oral suspension is i…
Excerpt only. Read the full label for complete information.
About NDC 68180-678
- What is NDC 68180-678?
- 68180-678 is the product NDC for Oseltamivir Phosphate, Oseltamivir phosphate 6 mg/mL powder, for suspension, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oseltamivir Phosphate.
- What is the active ingredient?
- Oseltamivir phosphate.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oseltamivir Phosphate?
- 107 other product NDCs are listed under this name. See all Oseltamivir Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oseltamivir Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oseltamivir Phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4770 | 70518-4770-00 |
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | For suspensionOral | Alembic Pharmaceuticals Limited | 46708-769 | 46708-0769-60 |
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | For suspensionOral | Alembic Pharmaceuticals Inc. | 62332-769 | 62332-0769-60 |
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | SuspensionOral | HEC Pharm USA Inc. | 72303-0851 | 72303-0851-01 |
| Oseltamivir Phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4066 | 68788-4066-01 |
| oseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-101 | 72673-0101-10 |
| oseltamivir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-102 | 72673-0102-10 |
| Oseltamivir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-321 | 42677-0321-01 |
| Oseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-320 | 42677-0320-01 |
| Oseltamivir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-322 | 42677-0322-01 |
Other NDCs under ANDA 208347
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 |
|---|---|---|---|---|
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-4188 |
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | Powder, For suspensionOral | Proficient Rx LP | 71205-489 |
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | Powder, For suspensionOral | Asclemed USA, Inc. | 76420-924 |