Ondansetron
- Product NDC
- 35356-678
- 11-digit product format
- 353560678
- Labeler code
- 35356
- Product ID
- 35356-678_4ed8da10-8532-416a-a31c-7f0ad0d22a38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA078139
- Marketing category
- ANDA
- Marketing start
- 2011-07-26
- 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 35356-678-20 | 2025-01-14 | C162847 | 48780-1 | ba0f9c33-3231-a910-e053-dadaa90a0b85 | 482162fc-1ea6-4012-ae59-76911a047821 |
| 35356-678-30 | 2025-01-14 | C162847 | 48780-1 | ba0f9c33-3231-a910-e053-dadaa90a0b85 | 482162fc-1ea6-4012-ae59-76911a047821 |
| 35356-678-20 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3231-a910-e053-dadaa90a0b85 | 482162fc-1ea6-4012-ae59-76911a047821 |
| 35356-678-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3231-a910-e053-dadaa90a0b85 | 482162fc-1ea6-4012-ae59-76911a047821 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35356-678-20 | EA - Each | 35356-678 | eb864b3f-6118-4fa3-8a41-f049dbb165f4 | 1 | 2017-09-11 |
| 35356-678-30 | EA - Each | 35356-678 | a2674d07-f0f2-45ca-be3e-fb7d060ca6d7 | 1 | 2012-07-24 |