NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1357Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1357Add 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
71335-1357-071335135700713351357005 TABLET, FILM COATED in 1 BOTTLE (71335-1357-0)Marketed from Apr 3, 2024
71335-1357-1713351357017133513570110 TABLET, FILM COATED in 1 BOTTLE (71335-1357-1)Marketed from Oct 14, 2019
71335-1357-2713351357027133513570215 TABLET, FILM COATED in 1 BOTTLE (71335-1357-2)Marketed from Jul 30, 2021
71335-1357-371335135703713351357034 TABLET, FILM COATED in 1 BOTTLE (71335-1357-3)Marketed from Apr 3, 2024
71335-1357-471335135704713351357043 TABLET, FILM COATED in 1 BOTTLE (71335-1357-4)Marketed from Apr 3, 2024
71335-1357-5713351357057133513570512 TABLET, FILM COATED in 1 BOTTLE (71335-1357-5)Marketed from Sep 30, 2021
71335-1357-6713351357067133513570620 TABLET, FILM COATED in 1 BOTTLE (71335-1357-6)Marketed from Sep 27, 2019
71335-1357-7713351357077133513570730 TABLET, FILM COATED in 1 BOTTLE (71335-1357-7)Marketed from Oct 1, 2019
71335-1357-8713351357087133513570860 TABLET, FILM COATED in 1 BOTTLE (71335-1357-8)Marketed from Jul 28, 2021
71335-1357-971335135709713351357096 TABLET, FILM COATED in 1 BOTTLE (71335-1357-9)Marketed from Feb 12, 2020

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 — 8 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 71335-1357_d48ed97a-a53e-4757-9712-cc4bf0acd961SPL ID d48ed97a-a53e-4757-9712-cc4bf0acd961SPL set ID 115e8fb5-61f5-4719-8eb3-063b7ca194aeRxCUI 312086UNII 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

N471335135700 followed by a unit qualifier and the quantity

Package 71335-1357-00. 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 71335-1357

What is NDC 71335-1357?
71335-1357 is the product NDC for Ondansetron Hydrochloride, Ondansetron hydrochloride 8 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

Showing 20 of 40.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in