Yosprala
- Product NDC
- 73568-004
- 11-digit product format
- 735680004
- Labeler code
- 73568
- Product ID
- 73568-004_ec415279-46cc-4cac-966e-1da27be91011
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- aspirin and omeprazole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PHARMACEUTIKA LTD
- Application
- NDA205103
- Marketing category
- NDA
- Marketing start
- 2020-01-30
- Marketing end
- 0000-00-00
- Substance
- ASPIRIN; OMEPRAZOLE
- Active strength
- 81 mg/1; mg/1
- Pharmacologic classes
- Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73568-004-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6611-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use YOSPRALA™ safely and effectively. See full prescribing information for YOSPRALA. YOSPRALA (aspirin and omeprazole) delayed-release tablets, for oral use Initial U.S. Approval: 2016 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73568-004-30 | Yosprala | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 73568-004-30 | EA - Each | 73568-004 | 9cf6273c-5c5c-4ed2-bbeb-b8e536befb08 | 1 | 2020-02-13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1811632 | aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet | PSN | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811631 | aspirin 81 MG / omeprazole 40 MG Delayed Release Oral Tablet | PSN | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811916 | Yosprala 325 MG / 40 MG Delayed Release Oral Tablet | PSN | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811918 | Yosprala 81 MG / 40 MG Delayed Release Oral Tablet | PSN | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811916 | aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala] | SBD | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811918 | aspirin 81 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala] | SBD | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811632 | aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet | SCD | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811631 | aspirin 81 MG / omeprazole 40 MG Delayed Release Oral Tablet | SCD | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811632 | ASA 325 MG / Omeprazole 40 MG Delayed Release Oral Tablet | SY | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811916 | ASA 325 MG / Omeprazole 40 MG Delayed Release Oral Tablet [Yosprala] | SY | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811631 | ASA 81 MG / Omeprazole 40 MG Delayed Release Oral Tablet | SY | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811918 | ASA 81 MG / Omeprazole 40 MG Delayed Release Oral Tablet [Yosprala] | SY | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811916 | Yosprala (aspirin 325 MG (delayed-release) / omeprazole 40 MG (immediate-release)) Delayed Release Oral Tablet | SY | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
| 1811918 | Yosprala (aspirin 81 MG (delayed-release) / omeprazole 40 MG (immediate-release)) Delayed Release Oral Tablet | SY | bce0eb08-7eac-4437-ba88-fafac350a8f6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 73568-004-30 | 73568000430 | 30 TABLET, FILM COATED in 1 BOTTLE (73568-004-30) | 2020-01-30 | 0000-00-00 | No | No | Current |