Ondansetron
- Product NDC
- 63187-002
- 11-digit product format
- 631870002
- Labeler code
- 63187
- Product ID
- 63187-002_19d4f41e-82d5-4eb2-94f7-de85f787725d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078050
- Marketing category
- ANDA
- Marketing start
- 2007-08-31
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON
- Active strength
- 4 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON | ACTIVE INGREDIENT | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
| STRAWBERRY | INACTIVE INGREDIENT | 4J2TY8Y81V | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-002 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP] | 7 | Legacy NDC | 20191121_bf2b41aa-8bac-4de7-98b2-884cbcee6c6c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-002-10 | 63187000210 | 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-002-10) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-002-15 | 63187000215 | 15 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-002-15) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-002-20 | 63187000220 | 20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-002-20) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-002-30 | 63187000230 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-002-30) | 2018-11-01 | 0000-00-00 | No | No | Current |