NDC 0641-6080-01 - 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: 0641-6080
Requested NDC: 0641-6080-01
Package NDCs from labels: 0641-6080-01, 0641-6080-25
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2026-04-16
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ondansetron - Hikma Pharmaceuticals USA Inc.	Hikma Pharmaceuticals USA Inc.	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2025-06-20	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6080-01	Ondansetron	2 mL in 1 VIAL	INJECTION	2		20
0641-6080-25	Ondansetron	25 in 1 CARTON	INJECTION	25		20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6080	ONDANSETRON INJECTION [HIKMA PHARMACEUTICALS USA INC.]	19	Current NDC, Legacy NDC, 2 package rows	20250327_97713356-f42b-4a67-95f6-561afa68c0c2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6080-01	ML - Milliliter	0641-6080	3ecda475-6cd1-4288-a0ec-a84a0d8d4fff	1	2012-07-24
0641-6080-25	ML - Milliliter	0641-6080	5d18bfb7-bded-4583-a5b2-da3b0433d322	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11

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 56 of 62 · 1,235 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACNE HP	CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC	Natural Creations, Inc.	b2368ab6-e233-4473-99fa-86e1fbc2a879	2022-02-14	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)	ANTICOAGULANT SODIUM CITRATE SOLUTION	Fenwal, Inc.	a63da38d-1fea-4ee0-a70b-55c891a5ebcc	2022-02-11		Exact identifier unii: B22547B95K
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)	ANTICOAGULANT SODIUM CITRATE SOLUTION	Fenwal, Inc.	ac8971a9-36d0-43c9-9121-ba5e58c28bed	2022-02-11		Exact identifier unii: B22547B95K
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	f62481fd-fcdb-4be6-ac13-29c590e925c3	2022-02-10	Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	e44c41ae-c9c8-4dd8-ba6c-cebb585378aa	2022-01-31	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Saline Mist Walgreens	SODIUM CHLORIDE	WALGREEN COMPANY	d6b9d4fc-b758-be32-e053-2995a90a2523	2022-01-29	Warnings	Exact identifier unii: 451W47IQ8X
Extra Strenght Saline Mist Rite Aid	SODIUM CHLORIDE	RITE AID CORPORATION	d5b30fb2-4052-4a0c-e053-2a95a90aacd5	2022-01-16	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Saline Mist Rite Aid	SODIUM CHLORIDE	RITE AID	d583067e-1133-7d7d-e053-2a95a90a1e36	2022-01-13	Warnings	Exact identifier unii: 451W47IQ8X
SinuCleanse Sterile Saline Mist	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC	648da2bc-bc91-4295-9e46-d3055cdc2418	2022-01-08	Warnings	Exact identifier unii: 451W47IQ8X
SinuCleanse Nasal Drip	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC	d5129a91-50e7-6b94-e053-2a95a90a2b30	2022-01-08	Warnings	Exact identifier unii: 451W47IQ8X
SinuCleanse Sterile Saline Mist Daily Care	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC	d5131ab2-8213-3659-e053-2a95a90ab2ab	2022-01-08	Warnings	Exact identifier unii: 451W47IQ8X
Headek Nasal	BELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR.	Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics	976b9c85-68c9-46a5-9012-53cb24683b03	2021-12-29	Warnings	Exact identifier unii: 451W47IQ8X
EAR RX	ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM	Miami Beach Pediatrics pa	a8753f88-4b8a-472f-a4bd-f2e9cec83610	2021-12-29	Warnings	Exact identifier unii: 451W47IQ8X
Lyme Disease Support 1	ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA.	OHM PHARMA INC.	035e75d6-aeef-4dfd-b076-9d3d8e4a5086	2021-12-29	Warnings	Exact identifier unii: 451W47IQ8X
Anxiety Stress Relief	ARG NIT, AUR MET, AVENA, GELSEMIUM, HYOSCYAMUS, IGNATIA, MOSCHUS, NAT MUR, PASSIFLORA, STANNUM MET, VALERIANA.	OHM PHARMA INC.	b736ec93-199a-4d19-882a-186c0e2adb11	2021-12-29	Warnings	Exact identifier unii: 451W47IQ8X
TH-101	CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROB	Temple Health Nutrition, LLC	d54bb860-560c-4f8f-9aea-a0b7774cc92b	2021-12-29	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4829ee40-c2d7-4e17-a606-75e8a8628413	2021-12-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Childrens Cold and Cough Grape Flavor	ONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFUR	Walgreen Company	7a2c09e5-0195-138c-e053-2a91aa0ae0a7	2021-12-21	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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