Granisetron Hydrochloride
- Product NDC
- 17478-546
- 11-digit product format
- 174780546
- Labeler code
- 17478
- Product ID
- 17478-546_bd8585c7-95d2-4e0b-a0d8-1da1596340fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Granisetron Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Akorn
- Application
- ANDA079078
- Marketing category
- ANDA
- Marketing start
- 2009-10-01
- Marketing end
- 0000-00-00
- Substance
- GRANISETRON HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17478-546-02 | Granisetron Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 15 |
| 17478-546-02 | Granisetron Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 15 |
| 17478-546-05 | Granisetron Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 15 |
| 17478-546-05 | Granisetron Hydrochloride | 4 mL in 1 VIAL, MULTI-DOSE | INJECTION | 4 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Granisetron Hydrochloride | ACTIVE INGREDIENT | 318F6L70J8 | GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.] | 8 | |
| Granisetron | ACTIVE MOIETY | WZG3J2MCOL | GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.] | 8 | |
| Benzyl Alcohol | INACTIVE INGREDIENT | LKG8494WBH | GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.] | 8 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.] | 8 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.] | 8 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.] | 8 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.] | 8 | |
| Trisodium Citrate Dihydrate | INACTIVE INGREDIENT | B22547B95K | GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.] | 8 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-546 | GRANISETRON HYDROCHLORIDE INJECTION [AKORN] | 15 | Legacy NDC, 4 package rows | 20220914_02f350c9-b7d2-4906-af28-70ed4461ff23.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 17478-546-02 | 17478054602 | 1 VIAL, SINGLE-DOSE in 1 CARTON (17478-546-02) > 1 mL in 1 VIAL, SINGLE-DOSE | 2009-10-01 | 0000-00-00 | No | No | Current |
| 17478-546-05 | 17478054605 | 1 VIAL, MULTI-DOSE in 1 CARTON (17478-546-05) > 4 mL in 1 VIAL, MULTI-DOSE | 2009-10-01 | 0000-00-00 | No | No | Current |