NDC codes

FDA NDC Directory
Product NDC (as listed)43063-857Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0857Add 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
43063-857-0243063085702430630857022 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-02)Marketed from Jun 4, 2018
43063-857-0443063085704430630857044 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-04)Marketed from Jun 12, 2018
43063-857-0543063085705430630857055 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-05)Marketed from Jun 12, 2018
43063-857-0643063085706430630857066 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-06)Marketed from Jun 4, 2018
43063-857-0843063085708430630857088 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-08)Marketed from Jun 7, 2018
43063-857-10430630857104306308571010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-10)Marketed from Jun 18, 2018
43063-857-20430630857204306308572020 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-20)Marketed from Aug 21, 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
Generic name (nonproprietary)
ondansetron
Active ingredients
Ondansetron — 4 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090469
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 43063-857_3ed995a4-00a5-c1d0-e063-6394a90a0298SPL ID 3ed995a4-00a5-c1d0-e063-6394a90a0298SPL set ID 9558d296-8edd-4aa1-875a-6247f9a8374dRxCUI 104894UNII 4AF302ESOSUPC 0343063857052

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

N443063085702 followed by a unit qualifier and the quantity

Package 43063-0857-02. 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 orally disintegrating 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 orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron orally disintegrating tablets are a 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogeni…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43063-857

What is NDC 43063-857?
43063-857 is the product NDC for Ondansetron, Ondansetron 4 mg/1 tablet, orally disintegrating, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 7 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 090469

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

FDA NDC Directory listings under ANDA 090469
ProductStrengthForm · routeLabelerProduct NDC
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals, Inc.68788-7644
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-4834
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack71335-1071
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralRising Pharma Holdings, Inc.57237-077
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals, Inc.68788-9559
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralRising Pharma Holdings, Inc.57237-078
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-4881
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralProficient Rx LP71205-713
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralDirect Rx61919-986
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-1551
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralSt. Mary's Medical Park Pharmacy60760-306
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAsclemed USA, Inc.76420-056
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack71335-0650
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-526
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPD-Rx Pharmaceuticals, Inc.43063-870
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNorthwind Health Company, LLC51655-809
Ondansetron ODTondansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAdvanced Rx of Tennessee, LLC80425-0073
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-2763
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralHAWAII REPACK, INC.85534-0025
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-1730

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