Ondansetron
- Product NDC
- 63629-5083
- 11-digit product format
- 636295083
- Labeler code
- 63629
- Product ID
- 63629-5083_a560c433-d99b-41fd-a807-f84eed2f6c70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077535
- Marketing category
- ANDA
- Marketing start
- 2007-06-25
- 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-5083 | ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | Legacy NDC | 20220217_a560c433-d99b-41fd-a807-f84eed2f6c70.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-5083-1 | 63629508301 | 10 TABLET, FILM COATED in 1 BOTTLE (63629-5083-1) | 2013-08-29 | 0000-00-00 | No | No | Current |
| 63629-5083-2 | 63629508302 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-5083-2) | 2022-02-08 | 0000-00-00 | No | No | Current |
| 63629-5083-3 | 63629508303 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-5083-3) | 2016-02-11 | 0000-00-00 | No | No | Current |