ondansetron hydrochloride
- Product NDC
- 0615-8185
- 11-digit product format
- 006158185
- Labeler code
- 0615
- Product ID
- 0615-8185_cb0b89ea-904e-424e-9213-80fc4d073fe3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA076183
- Marketing category
- ANDA
- Marketing start
- 2006-12-26
- 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
- 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 | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NMH84OZK2B |
| Rxcui | 198052 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8185-00 | ondansetron hydrochloride | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 22 |
| 0615-8185-05 | ondansetron hydrochloride | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 22 |
| 0615-8185-10 | ondansetron hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 22 |
| 0615-8185-12 | ondansetron hydrochloride | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | | 22 |
| 0615-8185-39 | ondansetron hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 22 |
| 0615-8185-50 | ondansetron hydrochloride | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8185 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 22 | Current NDC, Legacy NDC, 6 package rows | 20240426_00327696-c496-4c83-a63e-9e29fd6246d4.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 |
|---|
| 0615-8185-00 | 00615818500 | 5 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-00) | 2024-04-22 | | No | No | Historical |
| 0615-8185-05 | 00615818505 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-05) | 2020-03-24 | 0000-00-00 | No | No | Current |
| 0615-8185-10 | 00615818510 | 10 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-10) | 2018-11-07 | 0000-00-00 | No | No | Current |
| 0615-8185-12 | 00615818512 | 12 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-12) | 2024-01-26 | | No | No | Historical |
| 0615-8185-39 | 00615818539 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-39) | 2018-11-07 | 0000-00-00 | No | No | Current |
| 0615-8185-50 | 00615818550 | 5 in 1 BLISTER PACK | | | | | Historical |