granisetron hydrochloride
Generic: granisetron hydrochloride
Labeler: mylan institutional llcDrug Facts
Product Profile
Brand Name
granisetron hydrochloride
Generic Name
granisetron hydrochloride
Labeler
mylan institutional llc
Dosage Form
INJECTION, SOLUTION
Routes
Active Ingredients
granisetron hydrochloride .1 mg/mL
Manufacturer
Identifiers & Regulatory
Product NDC
67457-861
Product ID
67457-861_9baf50f5-8a78-4532-af34-57f5d0c74dae
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA091136
Listing Expiration
2027-12-31
Marketing Start
2018-03-21
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
67457861
Hyphenated Format
67457-861
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
granisetron hydrochloride (source: ndc)
Generic Name
granisetron hydrochloride (source: ndc)
Application Number
ANDA091136 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- .1 mg/mL
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING Granisetron Hydrochloride Injection, USP is supplied as follows: NDC Granisetron Hydrochloride Injection, USP Package Factor 67457-861-01 0.1 mg per mL Single-Dose Vial 5 vials per carton 67457-863-01 1 mg per mL Single-Dose Vial 1 vial per carton Single-dose vials contain no preservative. NDC Granisetron Hydrochloride Injection, USP Package Factor 67457-864-04 4 mg per 4 mL (1 mg per mL) Multiple-Dose Vial 1 vial per carton Multiple-dose vials contain methylparaben and propylparaben as preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Discard unused portion for the single-dose vials. Once the multiple-dose vial is penetrated, its contents should be used within 30 days. Discard Unused Portion 30 days after vial penetration Do not freeze. Protect from light. Retain vial in carton until time of use. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.
- Package/Label Display Panel NDC 67457-864-04 Granisetron Hydrochloride Injection, USP 4 mg/4 mL [1 mg (base)/mL]* For Intravenous Use Only Mylan Rx only Multiple-Dose Vial 4 mL Carton
- Package/Label Display Panel NDC 67457-863-01 Granisetron Hydrochloride Injection, USP 1 mg/mL* For Intravenous Use Only Mylan Rx only Single-Dose Vial 1 mg Carton
- Package/Label Display Panel NDC 67457-861-01 Granisetron Hydrochloride Injection, USP 0.1 mg/mL* For Intravenous Use Only Mylan Rx only 5 x 1 mL Single-Dose Vials 0.1 mg-Carton
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "9baf50f5-8a78-4532-af34-57f5d0c74dae", "openfda": {"unii": ["318F6L70J8"], "rxcui": ["240912", "543218", "1734399"], "spl_set_id": ["8d88adba-7f5e-4e97-84b3-6ca8ec98c023"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Granisetron Hydrochloride", "product_id": "67457-861_9baf50f5-8a78-4532-af34-57f5d0c74dae", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "67457-861", "generic_name": "Granisetron Hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Granisetron Hydrochloride", "active_ingredients": [{"name": "GRANISETRON HYDROCHLORIDE", "strength": ".1 mg/mL"}], "application_number": "ANDA091136", "marketing_category": "ANDA", "marketing_start_date": "20180321", "listing_expiration_date": "20271231"}