FDA.reportPublic FDA data

NDC 16714-221-12 - Granisetron 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
16714-221
Requested NDC
16714-221-12
Package NDCs from labels
16714-221-10, 16714-221-30, 16714-221-12, 16714-221-32, 16714-221-01
Manufacturer
Northstar Rx LLC | Orchid Pharma Ltd. | Orchid Healthcare (A Division of Orchid Pharma Ltd)
Effective date
2020-11-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Granisetron HydrochlorideNorthstar Rx LLC | Orchid Pharma Ltd. | Orchid Healthcare (A Division of Orchid Pharma Ltd)2020-11-16HUMAN PRESCRIPTION DRUG LABEL
Granisetron HydrochlorideNorthstar Rx LLC | Orchid Pharma Ltd | Orchid Healthcare (A Division of Orchid Pharma Ltd)2020-11-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-221-01EA - Each16714-22142e00df4-5287-41f6-845a-d7a52beee10412012-07-24
16714-221-10EA - Each16714-221a9d6a32a-68ff-4e43-a883-783c364bbcb512017-04-05
16714-221-12EA - Each16714-221796faa2f-aab6-4dba-8a95-d8ff8f04c7ca12017-04-05
16714-221-30EA - Each16714-2213d157402-ebab-4884-ba47-d986865965f612012-07-24
16714-221-32EA - Each16714-2210e95923e-1285-4aab-b3d8-12d16ee5735a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GRANISETRON HYDROCHLORIDEACTIVE INGREDIENT318F6L70J8GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]9
GRANISETRONACTIVE MOIETYWZG3J2MCOLGRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]9
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]9
GRANISETRON HYDROCHLORIDEACTIVE INGREDIENT318F6L70J8GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
GRANISETRONACTIVE MOIETYWZG3J2MCOLGRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7

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 1 ยท 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Granisetron HydrochlorideGRANISETRON HYDROCHLORIDEEugia US LLC783e9d68-2371-4fd4-8d7a-a5e36f8718d02025-04-24Warnings, Adverse reactionsExact identifier
unii: 318F6L70J8
GranisolGRANISETRON HYDROCHLORIDEIntra-Sana Laboratories2758eb4d-2fe0-4f74-b3f5-b4903009e97c2025-03-21Warnings, Adverse reactionsExact identifier
unii: 318F6L70J8
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Granisetron HydrochlorideGRANISETRON HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.df4b6775-4337-41e0-815a-b064d98c3fe12024-02-29Warnings, Adverse reactionsExact identifier
unii: 318F6L70J8
Granisetron HydrochlorideGRANISETRON HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e07862df-f324-4575-a1ef-f7e1cbab4c7a2024-01-04Warnings, Adverse reactionsExact identifier
unii: 318F6L70J8
Granisetron HydrochlorideGRANISETRON HYDROCHLORIDEBionpharma Inc.50b713d3-7ca8-465a-aefa-65ddbe17b9342023-12-16Warnings, Adverse reactionsExact identifier
application number: ANDA078678
unii: 318F6L70J8
GranisetronGRANISETRON HYDROCHLORIDEFresenius Kabi USA, LLCdddc8714-383f-4bc5-a468-ae89dbc802b42022-11-15Warnings, Adverse reactionsExact identifier
unii: 318F6L70J8
434276c5-ae66-497a-8e30-5d079507dcfa7094279a-281a-4e53-ab2a-23fedb8c778a2020-11-16Warnings, Adverse reactionsExact identifier
spl id: 434276c5-ae66-497a-8e30-5d079507dcfa
spl set id: 7094279a-281a-4e53-ab2a-23fedb8c778a
f02a151c-00f2-4098-9108-16169726ff9f03226fdd-8be5-49a7-b63c-62f08e75cd2d2020-11-16Warnings, Adverse reactionsExact identifier
spl id: f02a151c-00f2-4098-9108-16169726ff9f
spl set id: 03226fdd-8be5-49a7-b63c-62f08e75cd2d
Granisetron hydrochlorideGRANISETRON HYDROCHLORIDENatco Pharma Limitedd2be8de3-04fe-4e92-82b4-98d749b895962019-10-25Warnings, Adverse reactionsExact identifier
unii: 318F6L70J8
Granisetron HydrochlorideGRANISETRON HYDROCHLORIDEMylan Institutional LLC8d88adba-7f5e-4e97-84b3-6ca8ec98c0232017-08-31Warnings, Adverse reactionsExact identifier
unii: 318F6L70J8

Reported adverse events (FAERS/openFDA)#

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