Sumatriptan
- Product NDC
- 0527-1859
- 11-digit product format
- 005271859
- Labeler code
- 0527
- Product ID
- 0527-1859_1fca524e-6cf5-4782-b5d5-b37b101cd93a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sumatriptan
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA204841
- Marketing category
- ANDA
- Marketing start
- 2016-02-19
- Substance
- SUMATRIPTAN
- Active strength
- 20 mg/.1mL
- Pharmacologic classes
- Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59adc2ba-d5f0-4a52-b35a-cc77921a79d2 | Product name | 4 | 20250724 |
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 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 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| f6199b09-e585-7ceb-4b09-803cf5ce1ed1 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0527-1859-43 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0b33-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SUMATRIPTAN Nasal Spray, USP safely and effectively. See full prescribing information for SUMATRIPTAN Nasal Spray, USP . SUMATRIPTAN Nasal Spray, USP Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0527-1859-43 | Sumatriptan | 6 in 1 CARTON | SPRAY | 6 | 26 | |
| 0527-1859-43 | Sumatriptan | 0.1 mL in 1 BLISTER PACK | SPRAY | 0.1 | 26 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0527-1859-43 | EA - Each | 0527-1859 | b0465706-befd-4850-a3a0-a449ffeb8a61 | 1 | 2016-09-02 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314227 | SUMAtriptan 20 MG/ACTUAT Nasal Spray | PSN | 64efe12a-cc43-47e6-b3dc-21dab6ddae06 | 26 |
| 313159 | SUMAtriptan 5 MG/ACTUAT Nasal Spray | PSN | 64efe12a-cc43-47e6-b3dc-21dab6ddae06 | 26 |
| 314227 | sumatriptan 20 MG/ACTUAT Nasal Spray | SCD | 64efe12a-cc43-47e6-b3dc-21dab6ddae06 | 26 |
| 313159 | sumatriptan 5 MG/ACTUAT Nasal Spray | SCD | 64efe12a-cc43-47e6-b3dc-21dab6ddae06 | 26 |
| 314227 | sumatriptan 20 MG/0.1 ML Nasal Spray | SY | 64efe12a-cc43-47e6-b3dc-21dab6ddae06 | 26 |
| 313159 | sumatriptan 5 MG/0.1 ML Nasal Spray | SY | 64efe12a-cc43-47e6-b3dc-21dab6ddae06 | 26 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0527-1859-43 | 00527185943 | 6 BLISTER PACK in 1 CARTON (0527-1859-43) / .1 mL in 1 BLISTER PACK | 6 blister pack | 2016-02-19 | 0000-00-00 | No | No | Current |