ONDANSETRON HYDROCHLORIDE
- Product NDC
- 61919-465
- 11-digit product format
- 619190465
- Labeler code
- 61919
- Product ID
- 61919-465_34659398-1c42-27dd-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ONDANSETRON HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA077851
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61919-465-06 | ONDANSETRON HYDROCHLORIDE | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 2 |
| 61919-465-10 | ONDANSETRON HYDROCHLORIDE | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 2 |
| 61919-465-30 | ONDANSETRON HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 61919-465-60 | ONDANSETRON HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-465 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | Legacy NDC, 4 package rows | 20161111_2c94fed2-f880-44a9-8d10-93fa5713dcb4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 61919-465-06 | 61919046506 | 6 in 1 BOTTLE | Historical |
| 61919-465-10 | 61919046510 | 10 in 1 BOTTLE | Historical |
| 61919-465-30 | 61919046530 | 30 in 1 BOTTLE | Historical |
| 61919-465-60 | 61919046560 | 60 in 1 BOTTLE | Historical |