Prescription drug · ANDA
ondansetron hydrochloride NDC 0615-8185
Ondansetron hydrochloride 4 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8185-00 | 0061581850000615818500 | 5 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-00)Marketed from Apr 22, 2024 | |
| 0615-8185-05 | 0061581850500615818505 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-05)Marketed from Mar 24, 2020 | |
| 0615-8185-10 | 0061581851000615818510 | 10 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-10)Marketed from Nov 7, 2018 | |
| 0615-8185-12 | 0061581851200615818512 | 12 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-12)Marketed from Jan 26, 2024 | |
| 0615-8185-39 | 0061581853900615818539 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-39)Marketed from Nov 7, 2018 |
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)
- ondansetron hydrochloride
- Generic name (nonproprietary)
- ondansetron hydrochloride
- Active ingredients
- Ondansetron hydrochloride — 4 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076183
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0615-8185_cb0b89ea-904e-424e-9213-80fc4d073fe3SPL ID cb0b89ea-904e-424e-9213-80fc4d073fe3SPL set ID 00327696-c496-4c83-a63e-9e29fd6246d4RxCUI 198052UNII NMH84OZK2B
- Pharmacologic class
- Serotonin-3 Receptor Antagonist
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
N400615818500followed by a unit qualifier and the quantityPackage 00615-8185-00. 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)
Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . initial and repeat courses of moderately emetogenic cancer chemotherapy. radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or eq…
Excerpt only. Read the full label for complete information.
About NDC 0615-8185
- What is NDC 0615-8185?
- 0615-8185 is the product NDC for ondansetron hydrochloride, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ondansetron hydrochloride.
- What is the active ingredient?
- Ondansetron hydrochloride.
- Who is the labeler?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ondansetron hydrochloride?
- 76 other product NDCs are listed under this name. See all ondansetron hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ondansetron hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Ipca Laboratories Limited | 83980-017 | 83980-0017-1083980-0017-1383980-0017-97 |
| ondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Ipca Laboratories Limited | 83980-018 | 83980-0018-1083980-0018-1383980-0018-97 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-878 | 60760-0878-10 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-088 | 87441-0088-01 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-064 | 87441-0064-01 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1242 | 67046-1242-03 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Quality Care Products, LLC | 83008-074 | 83008-0074-2083008-0074-30 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4145 | 70518-4145-0070518-4145-0170518-4145-02+3 more |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8651 | 68788-8651-0168788-8651-0268788-8651-03+2 more |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8582 | 68788-8582-0168788-8582-0268788-8582-03+2 more |
Other NDCs under ANDA 076183
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 |
|---|---|---|---|---|
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1678 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7879 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3551 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1539 |
| Ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-154 |
| Ondansetronondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-153 |
| ondansetron hydrochloride | Ondansetron hydrochloride 16 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-155 |
| Ondansetronondansetron hydrochloride | Ondansetron hydrochloride 24 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-156 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6551 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6552 |