NDC codes

FDA NDC Directory
Product NDC (as listed)51655-415Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51655-0415Add 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
51655-415-04516550415044 TABLET, FILM COATED in 1 BOTTLE (51655-415-04)Marketed from Apr 12, 2018
51655-415-43516550415433 TABLET, FILM COATED in 1 BOTTLE (51655-415-43)Marketed from Dec 28, 2017
51655-415-535165504155310 TABLET, FILM COATED in 1 BOTTLE (51655-415-53)Marketed from Apr 24, 2018
51655-415-545165504155415 TABLET, FILM COATED in 1 BOTTLE (51655-415-54)Marketed from Dec 28, 2017
51655-415-55516550415555 TABLET, FILM COATED in 1 BOTTLE (51655-415-55)Marketed from Dec 7, 2017
51655-415-87516550415876 TABLET, FILM COATED in 1 BOTTLE (51655-415-87)Marketed from Oct 24, 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
Northwind Health Company, LLCNDC labeler code 51655
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 51655-415_4b42c5c3-2626-a1d3-e063-6294a90ab9d3SPL ID 4b42c5c3-2626-a1d3-e063-6294a90ab9d3SPL set ID 852a3251-bf28-5557-e053-2991aa0a4fbdRxCUI 198052UNII NMH84OZK2B

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

N451655041504 followed by a unit qualifier and the quantity

Package 51655-0415-04. 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.

Full label on DailyMed (opens in a new tab)

About NDC 51655-415

What is NDC 51655-415?
51655-415 is the product NDC for Ondansetron Hydrochloride, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. It has 6 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?
Northwind Health Company, LLC, NDC labeler code 51655. 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.

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

Other Ondansetron Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ondansetron hydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralIpca Laboratories Limited83980-01783980-0017-1083980-0017-1383980-0017-97
ondansetron hydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralIpca Laboratories Limited83980-01883980-0018-1083980-0018-1383980-0018-97
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-87860760-0878-10
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-08887441-0088-01
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-06487441-0064-01
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralCoupler LLC67046-124267046-1242-03
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralQuality Care Products, LLC83008-07483008-0074-2083008-0074-30
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-414570518-4145-0070518-4145-0170518-4145-02+2 more
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-865168788-8651-0168788-8651-0268788-8651-03+2 more
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-858268788-8582-0168788-8582-0268788-8582-03+2 more

All 77 Ondansetron Hydrochloride NDCs

Other NDCs under ANDA 078539

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

FDA NDC Directory listings under ANDA 078539
ProductStrengthForm · routeLabelerProduct NDC
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-159
OndansetronOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-160
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralPharmPak, Inc.54348-819
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralDirect_Rx61919-565
OndansetronOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3713
OndansetronOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3801
OndansetronOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4245
Ondansetron HCLOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0072
Ondansetron HCLOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0074
Ondansetron HCLOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0075
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralQPharma, Inc.42708-044
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralQPharma, Inc.42708-059
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralQPharma, Inc.42708-179
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-792
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3178
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3185
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4671
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6342
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralAvPAK50268-621
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralAvPAK50268-622

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