Granisetron Hydrochloride
- Product NDC
- 51991-735
- 11-digit product format
- 519910735
- Labeler code
- 51991
- Product ID
- 51991-735_1919cca7-47e5-4474-8ad1-a49275d4f85b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Granisetron Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA078969
- Marketing category
- ANDA
- Marketing start
- 2009-06-22
- Substance
- GRANISETRON HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Granisetron Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GRANISETRON HYDROCHLORIDE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 318F6L70J8 |
| Rxcui | 310599 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51991-735-20 | Granisetron Hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | | 12 |
| 51991-735-20 | Granisetron Hydrochloride | 2 in 1 CARTON | TABLET | 2 | | 12 |
| 51991-735-32 | Granisetron Hydrochloride | 2 in 1 BLISTER PACK | TABLET | 2 | | 12 |
| 51991-735-32 | Granisetron Hydrochloride | 1 in 1 CARTON | TABLET | 1 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GRANISETRON HYDROCHLORIDE | ACTIVE INGREDIENT | 318F6L70J8 | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | |
| GRANISETRON | ACTIVE MOIETY | WZG3J2MCOL | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-735 | GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | Current NDC, Legacy NDC, 4 package rows | 20240327_df4b6775-4337-41e0-815a-b064d98c3fe1.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 |
|---|
| 51991-735-20 | 51991073520 | 2 BLISTER PACK in 1 CARTON (51991-735-20) / 10 TABLET in 1 BLISTER PACK | 2 blister pack | 2009-06-22 | 0000-00-00 | No | No | Current |
| 51991-735-32 | 51991073532 | 1 BLISTER PACK in 1 CARTON (51991-735-32) / 2 TABLET in 1 BLISTER PACK | 1 blister pack | 2009-06-22 | 0000-00-00 | No | No | Current |