FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
57237-075
11-digit product format
572370075
Labeler code
57237
Product ID
57237-075_523d3416-6472-44c4-abc0-13df8f875e00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2007-07-31
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052, 312086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-075-30Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
57237-075-50Ondansetron Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-075-30EA - Each57237-07573768b4e-ca6f-4572-ba57-eb5bc69dc8a912016-04-04
57237-075-50EA - Each57237-0759804734c-bfd1-4d30-bb54-b3cb428a10ec12022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-075ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 2 package rows20231215_90e0e508-75f7-4c8b-bb38-898aa4c531c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN8585e68b-965f-4f95-a5df-eea023cd5f82105
198052ondansetron 4 MG Oral TabletSCD8585e68b-965f-4f95-a5df-eea023cd5f82105
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY8585e68b-965f-4f95-a5df-eea023cd5f82105
198052ondansetron HCl 4 MG Oral TabletPSNe2c0e86c-e7fc-48f9-a894-02da8761001c101
198052ondansetron 4 MG Oral TabletSCDe2c0e86c-e7fc-48f9-a894-02da8761001c101
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYe2c0e86c-e7fc-48f9-a894-02da8761001c101
198052ondansetron HCl 4 MG Oral TabletPSN674ea285-8f84-4603-9655-82200c523fe511
198052ondansetron HCl 4 MG Oral TabletPSN90e0e508-75f7-4c8b-bb38-898aa4c531c311
312086ondansetron HCl 8 MG Oral TabletPSN90e0e508-75f7-4c8b-bb38-898aa4c531c311
312086ondansetron HCl 8 MG Oral TabletPSN674ea285-8f84-4603-9655-82200c523fe511
198052ondansetron 4 MG Oral TabletSCD674ea285-8f84-4603-9655-82200c523fe511
198052ondansetron 4 MG Oral TabletSCD90e0e508-75f7-4c8b-bb38-898aa4c531c311
312086ondansetron 8 MG Oral TabletSCD90e0e508-75f7-4c8b-bb38-898aa4c531c311
312086ondansetron 8 MG Oral TabletSCD674ea285-8f84-4603-9655-82200c523fe511
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY90e0e508-75f7-4c8b-bb38-898aa4c531c311
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY674ea285-8f84-4603-9655-82200c523fe511
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY90e0e508-75f7-4c8b-bb38-898aa4c531c311
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY674ea285-8f84-4603-9655-82200c523fe511
198052ondansetron HCl 4 MG Oral TabletPSN681795c0-1037-e373-e053-2991aa0af7b25
198052ondansetron 4 MG Oral TabletSCD681795c0-1037-e373-e053-2991aa0af7b25
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY681795c0-1037-e373-e053-2991aa0af7b25
198052ondansetron HCl 4 MG Oral TabletPSN2e0b1b09-9e68-4728-82d5-1f86510a0f2a4
198052ondansetron HCl 4 MG Oral TabletPSN960e2104-18c3-4cfa-abf6-f1b30c4529184
198052ondansetron HCl 4 MG Oral TabletPSN852a3251-bf28-5557-e053-2991aa0a4fbd4
198052ondansetron 4 MG Oral TabletSCD2e0b1b09-9e68-4728-82d5-1f86510a0f2a4
198052ondansetron 4 MG Oral TabletSCD852a3251-bf28-5557-e053-2991aa0a4fbd4
198052ondansetron 4 MG Oral TabletSCD960e2104-18c3-4cfa-abf6-f1b30c4529184
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY960e2104-18c3-4cfa-abf6-f1b30c4529184
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY852a3251-bf28-5557-e053-2991aa0a4fbd4
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY2e0b1b09-9e68-4728-82d5-1f86510a0f2a4
198052ondansetron HCl 4 MG Oral TabletPSNf1e04ccb-60c4-4f9a-acd7-70b1c9bee0363
198052ondansetron HCl 4 MG Oral TabletPSN3a79fc2b-9ea3-a808-e063-6394a90ae7943
198052ondansetron 4 MG Oral TabletSCD3a79fc2b-9ea3-a808-e063-6394a90ae7943
198052ondansetron 4 MG Oral TabletSCDf1e04ccb-60c4-4f9a-acd7-70b1c9bee0363
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY3a79fc2b-9ea3-a808-e063-6394a90ae7943
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYf1e04ccb-60c4-4f9a-acd7-70b1c9bee0363
198052ondansetron HCl 4 MG Oral TabletPSN36d64400-2d13-4a1a-a1ca-4741cd3d3f1a2
198052ondansetron 4 MG Oral TabletSCD36d64400-2d13-4a1a-a1ca-4741cd3d3f1a2
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY36d64400-2d13-4a1a-a1ca-4741cd3d3f1a2
198052ondansetron HCl 4 MG Oral TabletPSN26a62675-50a8-5681-e063-6394a90a55211
198052ondansetron HCl 4 MG Oral TabletPSN7df06aee-5db2-9f4c-e053-2a91aa0aa3541
198052ondansetron HCl 4 MG Oral TabletPSN40106070-6a25-5b0e-e063-6394a90a41971
198052ondansetron 4 MG Oral TabletSCD7df06aee-5db2-9f4c-e053-2a91aa0aa3541
198052ondansetron 4 MG Oral TabletSCD40106070-6a25-5b0e-e063-6394a90a41971
198052ondansetron 4 MG Oral TabletSCD26a62675-50a8-5681-e063-6394a90a55211
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY7df06aee-5db2-9f4c-e053-2a91aa0aa3541
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY40106070-6a25-5b0e-e063-6394a90a41971
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY26a62675-50a8-5681-e063-6394a90a55211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-075-305723700753030 TABLET, FILM COATED in 1 BOTTLE (57237-075-30) 2007-07-310000-00-00NoNoCurrent
57237-075-5057237007550500 TABLET, FILM COATED in 1 BOTTLE (57237-075-50) 2022-10-040000-00-00NoNoCurrent