ONDANSETRON
- Product NDC
- 63304-459
- 11-digit product format
- 633040459
- Labeler code
- 63304
- Product ID
- 63304-459_ad113c32-f57c-4548-9882-c46b9a990bd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ONDANSETRON
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA077851
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ONDANSETRON
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ONDANSETRON HYDROCHLORIDE | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NMH84OZK2B |
| Rxcui | 198052, 312086 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-459-30 | ONDANSETRON | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-459 | ONDANSETRON TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20190919_834bc56a-657d-4733-9a60-47040cb5c7bf.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 |
|---|
| 63304-459-30 | 63304045930 | 30 TABLET, FILM COATED in 1 BOTTLE (63304-459-30) | 2007-06-25 | 0000-00-00 | No | No | Current |