SUSTOL
- Product NDC
- 47426-101
- 11-digit product format
- 474260101
- Labeler code
- 47426
- Product ID
- 47426-101_d4d4e836-ebba-4666-b6da-9d5a846dfcf8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- granisetron
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Heron Therapeutics, Inc.
- Application
- NDA022445
- Marketing category
- NDA
- Marketing start
- 2016-08-09
- Substance
- GRANISETRON
- Active strength
- 10 mg/.4mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SUSTOL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GRANISETRON | 10 mg/.4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WZG3J2MCOL |
| Rxcui | 1810484, 1810489 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 47426-101-01 | 2024-10-06 | C162847 | 48780-1 | 1e7a6dab-1c7c-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993 |
| 47426-101-01 | 2024-10-06 | C162847 | 48780-1 | 1e7a6dab-1c7c-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993 |
| 47426-101-06 | 2024-10-06 | C162847 | 48780-1 | 1e7a6dab-1c7c-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993 |
| 47426-101-06 | 2024-10-06 | C162847 | 48780-1 | 1e7a6dab-1c7c-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993 |
| 47426-101-01 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-1c7c-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993 |
| 47426-101-01 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-1c7c-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993 |
| 47426-101-06 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-1c7c-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993 |
| 47426-101-06 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-1c7c-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47426-101 | SUSTOL (GRANISETRON) INJECTION [HERON THERAPEUTICS, INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20241008_f7c7ffdd-8270-4030-bc1e-a1cb28a6de56.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 |
|---|
| 47426-101-01 | 47426010101 | 1 in 1 KIT | | | | | | Historical |
| 47426-101-06 | 47426010106 | 6 KIT in 1 CARTON (47426-101-06) / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS | 6 kit | 2016-08-09 | 0000-00-00 | No | No | Current |