Prescription drug · ANDA
Ondansetron Hydrochloride NDC 55700-631
Ondansetron hydrochloride 4 mg/1 · Tablet, Film coated · Oral · Quality Care Products LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55700-631-10 | 5570006311055700063110 | 10 TABLET, FILM COATED in 1 BOTTLE (55700-631-10)Marketed from May 25, 2018 | |
| 55700-631-20 | 5570006312055700063120 | 20 TABLET, FILM COATED in 1 BOTTLE (55700-631-20)Marketed from May 25, 2018 | |
| 55700-631-30 | 5570006313055700063130 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-631-30)Marketed from May 25, 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)
- Ondansetron Hydrochloride
- Generic name (nonproprietary)
- ondansetron hydrochloride
- Active ingredients
- Ondansetron hydrochloride — 4 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Quality Care Products LLCNDC labeler code 55700
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078539
- Marketing start
- Marketing end
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55700-631_a02a2f64-0dd6-4871-9b00-95d64bdede3eSPL ID a02a2f64-0dd6-4871-9b00-95d64bdede3eSPL set ID 89091629-d15e-4e95-aed8-8bc983c78302RxCUI 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
N455700063110followed by a unit qualifier and the quantityPackage 55700-0631-10. 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 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 equ…
Excerpt only. Read the full label for complete information.
About NDC 55700-631
- What is NDC 55700-631?
- 55700-631 is the product NDC for Ondansetron Hydrochloride, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by Quality Care Products LLC. It has 3 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?
- Quality Care Products LLC, NDC labeler code 55700. 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 078539
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/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8651 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | PharmPak, Inc. | 54348-819 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-119 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Pharmpak, Inc. | 54348-821 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-878 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-9368 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-9402 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-076 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-075 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-792 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3511 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-034 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-179 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1585 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-744 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1596 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4145 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6342 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-813 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-1562 |
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