NDC codes

FDA NDC Directory
Product NDC (as listed)63629-4306Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-4306Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
63629-4306-063629430600636294306003 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-0)Marketed from Aug 20, 2010
63629-4306-1636294306016362943060130 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-1)Marketed from Aug 19, 2013
63629-4306-2636294306026362943060210 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-2)Marketed from Aug 19, 2013
63629-4306-363629430603636294306035 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-3)Marketed from Aug 19, 2013
63629-4306-463629430604636294306044 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-4)Marketed from Aug 20, 2010
63629-4306-563629430605636294306056 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-5)Marketed from Aug 20, 2010
63629-4306-6636294306066362943060614 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-6)Marketed from Aug 20, 2010
63629-4306-7636294306076362943060760 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-7)Marketed from Aug 20, 2010
63629-4306-8636294306086362943060812 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-8)Marketed from Aug 20, 2010
63629-4306-9636294306096362943060990 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-9)Marketed from Aug 20, 2010

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
Generic name (nonproprietary)
ondansetron
Active ingredients
Ondansetron — 8 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077557
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63629-4306_d33adc9e-77b0-4e55-90ab-0944938ccf1aSPL ID d33adc9e-77b0-4e55-90ab-0944938ccf1aSPL set ID 384a5cfb-05dd-2b79-73f4-a01a47a9eb3eRxCUI 198052, 312087UNII 4AF302ESOS

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

N463629430600 followed by a unit qualifier and the quantity

Package 63629-4306-00. 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 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 is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetronis 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 equal to 50 mg/m 2 . (1) na…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-4306

What is NDC 63629-4306?
63629-4306 is the product NDC for Ondansetron, Ondansetron 8 mg/1 tablet, orally disintegrating, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ondansetron.
What is the active ingredient?
Ondansetron.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 63629. 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?
190 other product NDCs are listed under this name. See all Ondansetron NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ondansetron NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-468570518-4685-00
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals Inc.68788-413368788-4133-0168788-4133-03
OndansetronOndansetron hydrochloride 4 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-488200121-4882-94
OndansetronOndansetron hydrochloride 4 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-088200121-0882-51
OndansetronOndansetron hydrochloride 2 mg/mLInjectionIntramuscular, IntravenousJVET PHARMACEUTICALS LLC86211-11586211-0115-01
OndansetronOndansetron hydrochloride 4 mg/1TabletOralREMEDYREPACK INC.70518-458870518-4588-00
OndansetronOndansetron hydrochloride 2 mg/mLInjection, SolutionIntramuscular, IntravenousHospira, Inc.0409-227100409-2271-25
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAvKARE42291-45742291-0457-30
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAvKARE42291-45842291-0458-30
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralSt. Mary's Medical Park Pharmacy60760-93660760-0936-10

All 191 Ondansetron NDCs

Other NDCs under ANDA 077557

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077557
ProductStrengthForm · routeLabelerProduct NDC
ondansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralCardinal Health 107, LLC55154-4567
ondansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralSun Pharmaceutical Industries, Inc.62756-240
ondansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralSun Pharmaceutical Industries, Inc.62756-356
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-670
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-693
ondansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-2284
ondansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-5230

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