NDC 65162-691-37 - Ondansetron

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 65162-691
Requested NDC: 65162-691-37
Package NDCs from labels: 65162-691-79, 65162-691-37, 65162-691-19
Manufacturer: American Health Packaging
Effective date: 2026-06-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ondansetron - American Health Packaging	American Health Packaging	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals, LLC	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals, LLC	2025-09-23	HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - ATLANTIC BIOLOGICALS CORP.	ATLANTIC BIOLOGICALS CORP.	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Major Pharmaceuticals	Major Pharmaceuticals	2025-03-27	HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Lohxa	Lohxa	2021-02-25	HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Atlantic Biologicals Corps	Atlantic Biologicals Corps	2011-06-10	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-691-19	Ondansetron	10 in 1 TRAY	SOLUTION	10	26
65162-691-37	Ondansetron	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	26
65162-691-79	Ondansetron	50 mL in 1 BOTTLE	SOLUTION	50	26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-691	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS LLC]	23	Current NDC, Legacy NDC, 3 package rows	20250207_38435346-d505-4bdd-bbc6-a7bcba411033.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-691-79	ML - Milliliter	65162-691	48b2fbd9-f85a-44af-8eac-f06bf677760e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 37 · 730 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Eye Drops Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Cardinal Health	aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a	2026-09-09	Warnings	Exact identifier unii: PDC6A3C0OX
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Rite Aid Corporation	407c78ca-6fee-4ed6-b61b-711ec049c86e	2026-09-09	Warnings	Exact identifier unii: PDC6A3C0OX
Clear Eyes Nighttime	GLYCERIN	Prestige Brands Holdings, Inc.	af75e2f7-81dd-43e0-a390-b52bbfbebf62	2026-09-08	Warnings	Exact identifier unii: PDC6A3C0OX
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	CVS Pharmacy	3167c918-a7d3-46a1-a85b-64f9c22916f2	2026-09-04	Warnings	Exact identifier unii: PDC6A3C0OX
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	416be720-82e8-4a6d-8531-c1a29869daae	2026-09-01	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
KUGIG ALOE FOAMING INTIMATE WASH	INTIMATE CLEANSING FOAM	Hong Kong KangXing Centennial Management Limited	59f4d398-1186-a168-e063-6294a90ab44b	2026-08-26	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	REMEDYREPACK INC.	5dd5d148-6e23-41de-bff5-551b2aea9598	2026-08-24	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
ondansetron	ONDANSETRON HYDROCHLORIDE	Major Pharmaceuticals	a29b5c18-9884-4c88-8827-65d9ad5f69f6	2026-08-21	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
ondansetron	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	37de0550-a6d1-46a8-a0b8-447b0dcf70ad	2026-08-19	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Unit Dose Solutions, Inc.	5566aebb-d84d-6d6a-e063-6294a90a746f	2026-08-18	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Leader Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	CARDINAL HEALTH 110, LLC. DBA LEADER	2ded4bda-b3c3-4521-8701-5c8446fd148b	2026-08-17	Warnings	Exact identifier unii: PDC6A3C0OX
BM BM63 DROPS	CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN	BM Private Limited	59006d82-610a-2e08-e063-6394a90af1ed	2026-08-14	Warnings	Exact identifier unii: 059QF0KO0R
BM BM164 DROPS	ARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUM	BM Private Limited	5902770f-eb01-d099-e063-6394a90ad3eb	2026-08-14	Warnings	Exact identifier unii: PDC6A3C0OX
Adaptopath	ADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUM	Energetix Corporation	41234598-0cb5-41c2-bfbe-1c15ee9bf502	2026-08-11	Warnings	Exact identifier unii: XF417D3PSL
Aller-Chord A	ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE	Energetix Corporation	09e89c92-112d-4320-9df5-b9f938bb9095	2026-08-11	Warnings	Exact identifier unii: XF417D3PSL
Hepatic-Tone	CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALE	Energetix Corporation	d5f61f13-7e9f-4e46-8ad8-0336f36288df	2026-08-11	Warnings	Exact identifier unii: XF417D3PSL
Isopathic Phenolic Rings	HOMEOPATHIC LIQUID	Energetix Corporation	98a7ca26-ccb7-43c7-bd65-892fcbacc882	2026-08-11	Warnings	Exact identifier unii: XF417D3PSL
Metabopath	ADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,	Energetix Corporation	58bfe670-d308-45a2-8046-7897b6221452	2026-08-11	Warnings	Exact identifier unii: XF417D3PSL
Sterile Water	WATER	Cardinal Health 107, LLC	48d75a7c-8329-48a8-bea0-a8c144ddf637	2026-08-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2a30d534-4607-4882-865e-56d2364acaad	2026-08-07	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.