Prescription drug · ANDA
Ondansetron Hydrochloride NDC 62135-555
Ondansetron hydrochloride 4 mg/5mL · Solution · Oral · Chartwell RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-555-24 | 62135055524 | 2 TRAY in 1 BOX (62135-555-24) / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-555-45)Marketed from May 28, 2024 | |
| 62135-555-58 | 62135055558 | 50 mL in 1 BOTTLE (62135-555-58)Marketed from Oct 4, 2022 |
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)
- Ondansetron Hydrochloride
- Generic name (nonproprietary)
- ondansetron hydrochloride
- Active ingredients
- Ondansetron hydrochloride — 4 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLC.NDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091342
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62135-555_476a94c7-d201-ccb7-e063-6294a90a8cd9SPL ID 476a94c7-d201-ccb7-e063-6294a90a8cd9SPL set ID 2086bae8-7c3c-4663-93ac-c86407c524c2RxCUI 312085UNII NMH84OZK2BUPC 0362135555580
- 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
N462135055524followed by a unit qualifier and the quantityPackage 62135-0555-24. 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 oral solution is 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 oral solution is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron is a 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 62135-555
- What is NDC 62135-555?
- 62135-555 is the product NDC for Ondansetron Hydrochloride, Ondansetron hydrochloride 4 mg/5mL solution, listed with the FDA by Chartwell RX, LLC.. It has 2 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?
- Chartwell RX, LLC., NDC labeler code 62135. 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+2 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 091342
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 Hydrochloride | Ondansetron hydrochloride 4 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-555 |