ondansetron hydrochloride
- Product NDC
- 55111-155
- 11-digit product format
- 551110155
- Labeler code
- 55111
- Product ID
- 55111-155_9064dccd-0ae4-688a-3216-6ced5e514340
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA076183
- Marketing category
- ANDA
- Marketing start
- 2006-12-26
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 16 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 hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ONDANSETRON HYDROCHLORIDE | 16 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NMH84OZK2B |
| Rxcui | 692695 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-155-05 | ondansetron hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 55111-155-30 | ondansetron hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 55111-155-78 | ondansetron hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 3 |
| 55111-155-79 | ondansetron hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ondansetron Hydrochloride | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
| Ondansetron | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
| colloidal silicon dioxide | INACTIVE INGREDIENT | | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
| hypromellose | INACTIVE INGREDIENT | | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
| microcrystalline cellulose | INACTIVE INGREDIENT | | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
| polyethylene glycol | INACTIVE INGREDIENT | | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
| pregelatinized starch | INACTIVE INGREDIENT | | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
| sodium starch glycolate | INACTIVE INGREDIENT | | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-155 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 3 | Current NDC, Legacy NDC, 4 package rows | 20210604_476e704c-95ae-4591-94f7-ee4ab827ff13.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55111-155-05 | 55111015505 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-155-05) | | 2006-12-26 | 0000-00-00 | No | No | Current |
| 55111-155-30 | 55111015530 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-155-30) | | 2006-12-26 | 0000-00-00 | No | No | Current |
| 55111-155-78 | 55111015578 | 10 BLISTER PACK in 1 CARTON (55111-155-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-155-79) | 10 blister pack | 2006-12-26 | 0000-00-00 | No | No | Current |
| 55111-155-79 | 55111015579 | 10 in 1 BLISTER PACK | | | | | | Historical |