Ondansetron
- Product NDC
- 68462-106
- 11-digit product format
- 684620106
- Labeler code
- 68462
- Product ID
- 68462-106_32177a6a-8c35-4e1c-b7f5-7376b1c1316a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA077535
- Marketing category
- ANDA
- Marketing start
- 2007-06-25
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 8 mg/1
- 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
- Ondansetron
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ONDANSETRON HYDROCHLORIDE | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NMH84OZK2B, 4AF302ESOS |
| Rxcui | 104894, 198052, 312086, 312087 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-106-30 | Ondansetron | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 17 |
| 68462-106-33 | Ondansetron | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | | 17 |
| 68462-106-33 | Ondansetron | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON | ACTIVE INGREDIENT | 4AF302ESOS | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-106 | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 16 | Current NDC, Legacy NDC, 3 package rows | 20240104_eee5217a-eba8-463a-812d-bf3c66f0934f.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 |
|---|
| 68462-106-30 | 68462010630 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-106-30) | | 2007-06-25 | 0000-00-00 | No | No | Current |
| 68462-106-33 | 68462010633 | 1 BLISTER PACK in 1 CARTON (68462-106-33) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2007-06-25 | 0000-00-00 | No | No | Current |