ZEMBRACE SymTouch
- Product NDC
- 67857-809
- 11-digit product format
- 678570809
- Labeler code
- 67857
- Product ID
- 67857-809_30c45ab6-7687-a85b-9f68-55198481dbad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sumatriptan
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Promius Pharma, LLC
- Application
- NDA208223
- Marketing category
- NDA
- Marketing start
- 2016-02-22
- Marketing end
- 0000-00-00
- Substance
- SUMATRIPTAN SUCCINATE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59adc2ba-d5f0-4a52-b35a-cc77921a79d2 | Product name | 4 | 20250724 |
| 2839c963-7eb3-970a-287f-ff1b6d381268 | Product name | 2 | 20250103 |
| 1e973b2d-e028-69cd-9258-4613ba80fdc5 | Product name | 3 | 20210512 |
| 3eb481d3-8b69-436f-82dd-4a66345568ab | Product name | 1 | 20190611 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| c100f0c7-e9dd-42f4-b0a8-0d81bd2a877c | Product name | 1 | 20160303 |
| 49615343-b619-4365-8118-8f2ed6046e78 | Product name | 1 | 20160224 |
| a6319377-430a-43db-82f9-30d1d9d89cf8 | Product name | 1 | 20151216 |
| f6199b09-e585-7ceb-4b09-803cf5ce1ed1 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67857-809-38 | 2023-01-30 | C162847 | 48780-1 | f386c649-a8cc-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZEMBRACE™ SymTouch™ safely and effectively. See full prescribing information for ZEMBRACE™ SymTouch™. ZEMBRACE™ SymTouch™ (sumatriptan succinate) Injection, for subcutaneous use Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67857-809-37 | ZEMBRACE SymTouch | 1 in 1 SYRINGE | INJECTION, SOLUTION | 1 | 5 | |
| 67857-809-38 | ZEMBRACE SymTouch | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67857-809-37 | ML - Milliliter | 67857-809 | fe49d010-92f1-4d8c-99fb-0b34d0ad70f8 | 1 | 2016-04-04 |
| 67857-809-38 | ML - Milliliter | 67857-809 | f2a2905a-68c7-4cdc-a171-a0713dac0746 | 1 | 2016-04-04 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1738576 | SUMAtriptan 3 MG in 0.5 ML Auto-Injector | PSN | d565763d-b740-411d-bbb4-13536017d634 | 5 |
| 1738581 | Zembrace 3 MG in 0.5 ML Auto-Injector | PSN | d565763d-b740-411d-bbb4-13536017d634 | 5 |
| 1738581 | 0.5 ML sumatriptan 6 MG/ML Auto-Injector [Zembrace] | SBD | d565763d-b740-411d-bbb4-13536017d634 | 5 |
| 1738576 | 0.5 ML sumatriptan 6 MG/ML Auto-Injector | SCD | d565763d-b740-411d-bbb4-13536017d634 | 5 |
| 1738576 | sumatriptan (as succinate) 3 MG per 0.5 ML Auto-Injector | SY | d565763d-b740-411d-bbb4-13536017d634 | 5 |
| 1738576 | sumatriptan 3 MG per 0.5 ML Auto-Injector | SY | d565763d-b740-411d-bbb4-13536017d634 | 5 |
| 1738581 | Zembrace 3 MG per 0.5 ML Auto-Injector | SY | d565763d-b740-411d-bbb4-13536017d634 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67857-809-37 | 67857080937 | 1 in 1 SYRINGE | Historical | |||||
| 67857-809-38 | 67857080938 | 4 SYRINGE in 1 CARTON (67857-809-38) > 1 INJECTION, SOLUTION in 1 SYRINGE (67857-809-37) | 4 syringe | 2016-02-22 | 0000-00-00 | No | No | Current |