NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1596Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1596Add 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
71335-1596-0713351596007133515960060 TABLET, FILM COATED in 1 BOTTLE (71335-1596-0)Marketed from Feb 14, 2022
71335-1596-1713351596017133515960110 TABLET, FILM COATED in 1 BOTTLE (71335-1596-1)Marketed from Feb 14, 2022
71335-1596-271335159602713351596023 TABLET, FILM COATED in 1 BOTTLE (71335-1596-2)Marketed from Feb 14, 2022
71335-1596-3713351596037133515960330 TABLET, FILM COATED in 1 BOTTLE (71335-1596-3)Marketed from Jun 8, 2020
71335-1596-4713351596047133515960415 TABLET, FILM COATED in 1 BOTTLE (71335-1596-4)Marketed from Feb 14, 2022
71335-1596-571335159605713351596056 TABLET, FILM COATED in 1 BOTTLE (71335-1596-5)Marketed from Apr 21, 2021
71335-1596-671335159606713351596064 TABLET, FILM COATED in 1 BOTTLE (71335-1596-6)Marketed from Feb 14, 2022
71335-1596-7713351596077133515960790 TABLET, FILM COATED in 1 BOTTLE (71335-1596-7)Marketed from Feb 14, 2022
71335-1596-8713351596087133515960812 TABLET, FILM COATED in 1 BOTTLE (71335-1596-8)Marketed from Feb 14, 2022
71335-1596-9713351596097133515960920 TABLET, FILM COATED in 1 BOTTLE (71335-1596-9)Marketed from Feb 14, 2022

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 71335-1596_7da5fba5-a99b-4351-a389-a62689478ed6SPL ID 7da5fba5-a99b-4351-a389-a62689478ed6SPL set ID 3f2e8efe-7fd4-407c-a77b-bd6dd04608e2RxCUI 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

N471335159600 followed by a unit qualifier and the quantity

Package 71335-1596-00. 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 71335-1596

What is NDC 71335-1596?
71335-1596 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?
78 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 79 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 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
Ondansetron HCLOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0072

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