Ondansetron
- Product NDC
- 45963-538
- 11-digit product format
- 459630538
- Labeler code
- 45963
- Product ID
- 45963-538_e47fbea6-9ab8-434c-82bf-5995f17a6d4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ACTAVIS PHARMA, INC.
- Application
- ANDA077851
- Marketing category
- ANDA
- Marketing start
- 2007-07-27
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ONDANSETRON TABLET, FILM COATED [ACTAVIS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45963-538 | ONDANSETRON TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 8 | Legacy NDC | 20240117_90d19fd2-6de4-4e55-9469-53b8957c8326.zip |
| 45963-538 | SUMANSETRON (SUMATRIPTAN SUCCINATE, ONDANSETRON) KIT [PURETEK CORPORATION] | 2 | Legacy NDC | 20230112_b69f0762-a2f7-28c7-e053-2995a90a0484.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 |
|---|
| 45963-538-30 | 45963053830 | 30 TABLET, FILM COATED in 1 BOTTLE (45963-538-30) | 2007-07-27 | 0000-00-00 | No | No | Current |