NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1855Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1855Add 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
71335-1855-0713351855007133518550060 TABLET, FILM COATED in 1 BOTTLE (71335-1855-0)Marketed from Dec 21, 2021
71335-1855-1713351855017133518550110 TABLET, FILM COATED in 1 BOTTLE (71335-1855-1)Marketed from Dec 21, 2021
71335-1855-271335185502713351855023 TABLET, FILM COATED in 1 BOTTLE (71335-1855-2)Marketed from Dec 21, 2021
71335-1855-3713351855037133518550330 TABLET, FILM COATED in 1 BOTTLE (71335-1855-3)Marketed from Dec 21, 2021
71335-1855-4713351855047133518550415 TABLET, FILM COATED in 1 BOTTLE (71335-1855-4)Marketed from Dec 21, 2021
71335-1855-571335185505713351855056 TABLET, FILM COATED in 1 BOTTLE (71335-1855-5)Marketed from Dec 21, 2021
71335-1855-671335185506713351855064 TABLET, FILM COATED in 1 BOTTLE (71335-1855-6)Marketed from Dec 21, 2021
71335-1855-7713351855077133518550790 TABLET, FILM COATED in 1 BOTTLE (71335-1855-7)Marketed from Dec 21, 2021
71335-1855-8713351855087133518550812 TABLET, FILM COATED in 1 BOTTLE (71335-1855-8)Marketed from Dec 21, 2021
71335-1855-9713351855097133518550920 TABLET, FILM COATED in 1 BOTTLE (71335-1855-9)Marketed from Dec 21, 2021

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
Bryant Ranch PrepackNDC labeler code 71335
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 71335-1855_9a6c7ef2-c4e5-4846-b234-dec3c4a0c847SPL ID 9a6c7ef2-c4e5-4846-b234-dec3c4a0c847SPL set ID 8585e68b-965f-4f95-a5df-eea023cd5f82RxCUI 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

N471335185500 followed by a unit qualifier and the quantity

Package 71335-1855-00. 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 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 71335-1855

What is NDC 71335-1855?
71335-1855 is the product NDC for Ondansetron Hydrochloride, Ondansetron hydrochloride 4 mg/1 tablet, film coated, 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 Hydrochloride.
What is the active ingredient?
Ondansetron hydrochloride.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 71335. 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+3 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
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8651
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralPharmPak, Inc.54348-819
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-119
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralPharmpak, Inc.54348-821
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-878
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-9368
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-9402
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-076
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-075
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-792
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3511
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-034
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralQPharma, Inc.42708-179
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1585
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralProficient Rx LP71205-744
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1596
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4145
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6342
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-813
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralRedpharm Drug67296-1562

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