Prescription drug · ANDA
Ondansetron Hydrochloride NDC 68788-8651
Ondansetron hydrochloride 4 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8651-1 | 6878886510168788865101 | 10 TABLET, FILM COATED in 1 BOTTLE (68788-8651-1)Marketed from Apr 29, 2024 | |
| 68788-8651-2 | 6878886510268788865102 | 12 TABLET, FILM COATED in 1 BOTTLE (68788-8651-2)Marketed from Apr 29, 2024 | |
| 68788-8651-3 | 6878886510368788865103 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8651-3)Marketed from Apr 29, 2024 | |
| 68788-8651-5 | 6878886510568788865105 | 15 TABLET, FILM COATED in 1 BOTTLE (68788-8651-5)Marketed from Apr 29, 2024 | |
| 68788-8651-6 | 6878886510668788865106 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8651-6)Marketed from Apr 29, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078539
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68788-8651_4fecd4f1-85d1-46e3-b5e3-164b04b05e89SPL ID 4fecd4f1-85d1-46e3-b5e3-164b04b05e89SPL set ID 36d64400-2d13-4a1a-a1ca-4741cd3d3f1aRxCUI 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
N468788865101followed by a unit qualifier and the quantityPackage 68788-8651-01. 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)
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 tha…
Excerpt only. Read the full label for complete information.
About NDC 68788-8651
- What is NDC 68788-8651?
- 68788-8651 is the product NDC for Ondansetron Hydrochloride, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 8 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8582 | 68788-8582-0168788-8582-0268788-8582-03+2 more |
| ondansetron hydrochloride | Ondansetron hydrochloride 2 mg/mL | InjectionIntramuscular, Intravenous | Onesource Specialty Pharma Limited | 83270-160 | 83270-0160-03 |
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 | 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 |
| Ondansetron HCL | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0072 |
Showing 20 of 39.