NDC 85509-1075-01 - Ondansetron Hydrochloride

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
85509-1075
Requested NDC
85509-1075-01
Package NDCs from labels
85509-1075-3, 85509-1075-1, 85509-1075-6, 85509-1075-2, 85509-1075-5, 85509-1075-4, 85509-1075-01
Manufacturer
PHOENIX RX LLC
Effective date
2025-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ondansetron Hydrochloride - PHOENIX RX LLCPHOENIX RX LLC2025-09-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1075-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED103
85509-1075-2Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
85509-1075-3Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
85509-1075-4Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED123
85509-1075-5Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
85509-1075-6Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1075-1EA - Each85509-107543a87875-3559-47aa-9077-2bc95628927912025-09-12
85509-1075-2EA - Each85509-1075c2638373-f545-4952-a88e-953d2a73b58112025-09-12
85509-1075-3EA - Each85509-107599ee1d89-04b6-4b1b-b35b-d0d40c2375cd12025-09-12
85509-1075-4EA - Each85509-1075559baff1-fd35-4769-8755-8597aa072f3112025-10-14
85509-1075-5EA - Each85509-10759348dfe6-6a63-46b1-b8b9-142a9bff4b9d12025-09-12
85509-1075-6EA - Each85509-10759a0114f6-bed8-4b4d-a775-774ac88ea76912025-09-12

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 102 of 107 · 2,121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
unii: 15FIX9V2JP
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEA-S Medication Solutionsf8f371c7-09f8-426c-ae22-753cd5626da32023-01-23Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 198052
unii: NMH84OZK2B
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
SumansetronSUMATRIPTAN SUCCINATE, ONDANSETRONPureTek Corporationb69f0762-a2f7-28c7-e053-2995a90a04842023-01-11Warnings, Adverse reactionsExact identifier
rxcui: 198052
ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirst993cd1d7-70a1-a431-e053-2a95a90a57712022-12-10Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONPharmPak, Inc.8e289184-6046-4b55-97d2-cb276d5782d52022-10-09Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPharmpak, Inc.e41b9469-e844-47d9-933a-4c9f4453ecc72022-10-09Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 312086
unii: NMH84OZK2B
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 15FIX9V2JP
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEProficient Rx LP69ed01b7-a94e-4946-a044-a9f8c37616ec2022-05-02Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 312086
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEProficient Rx LP381b44e7-a5a1-42ad-bcea-1ab4c82ff5d42022-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 198052
unii: NMH84OZK2B
ONDANSETRONONDANSETRONQilu Pharmaceutical Co., Ltd.5e09e262-dadf-4ae0-825e-448ea8dac1742022-03-02Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS97e7ece8-a705-4988-ba52-6d3f115735212021-12-01WarningsExact identifier
unii: 15FIX9V2JP
OndansetronONDANSETRON TABLETSNatco Pharma Limited59c817b7-a1c6-48a5-9bfc-2c381532bfd92021-11-29Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 ChestnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS6a44f926-11b4-4bc4-8d5d-721a89c4f0cc2021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 HazelnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASb58af664-b0fd-4585-8417-7c20954d7aff2021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 UmberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS7bbd1334-fae8-4274-b927-a099af7643452021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 CedarOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS970571f9-3d6b-46ae-a668-745de1911fa22021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 WheatOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS542e1b2e-f63c-466b-b5ac-6c147a0e9dec2021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS21b65c12-6f67-4053-9508-6b2709cc1fb82021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS8ea4c470-ebd5-448e-b72a-ccd1113de0ab2021-11-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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