Zolmitriptan
- Product NDC
- 16571-804
- 11-digit product format
- 165710804
- Labeler code
- 16571
- Product ID
- 16571-804_fcf22883-8cbb-4185-99ba-5be1bcfb9306
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolmitriptan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA207021
- Marketing category
- ANDA
- Marketing start
- 2016-05-11
- Substance
- ZOLMITRIPTAN
- Active strength
- 5 mg/1
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zolmitriptan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLMITRIPTAN | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2FS66TH3YW |
| Rxcui | 200193, 200194 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-804-13 | Zolmitriptan | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
| 16571-804-13 | Zolmitriptan | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-804 | ZOLMITRIPTAN TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240301_5fcdc5d6-38fa-458d-a581-4e3678a9e8fd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16571-804-13 | 16571080413 | 1 BLISTER PACK in 1 CARTON (16571-804-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2016-05-11 | 0000-00-00 | No | No | Current |