Granisetron
- Product NDC
- 63323-319
- 11-digit product format
- 633230319
- Labeler code
- 63323
- Product ID
- 63323-319_fd73c3f4-aa7d-4c2f-ab74-1883910ea086
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GRANISETRON HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA078090
- Marketing category
- ANDA
- Marketing start
- 2009-11-20
- Marketing end
- 2024-05-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-319-04 | Granisetron | 4 mL in 1 VIAL | INJECTION, SOLUTION | 4 | | 9 |
| 63323-319-04 | Granisetron | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GRANISETRON HYDROCHLORIDE | ACTIVE INGREDIENT | 318F6L70J8 | GRANISETRON (GRANISETRON HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | |
| GRANISETRON | ACTIVE MOIETY | WZG3J2MCOL | GRANISETRON (GRANISETRON HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | GRANISETRON (GRANISETRON HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | GRANISETRON (GRANISETRON HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | GRANISETRON (GRANISETRON HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | GRANISETRON (GRANISETRON HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-319 | GRANISETRON (GRANISETRON HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 | Legacy NDC, 2 package rows | 20221221_dddc8714-383f-4bc5-a468-ae89dbc802b4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-319-04 | 63323031904 | 1 VIAL in 1 BOX (63323-319-04) > 4 mL in 1 VIAL | 1 vial | 2009-11-20 | 0000-00-00 | No | No | Current |