ZOMIG
- Product NDC
- 64896-083
- 11-digit product format
- 648960083
- Labeler code
- 64896
- Product ID
- 64896-083_00c29925-0e82-4be0-b335-efb0e4ffa0fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolmitriptan
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- NDA021450
- Marketing category
- NDA
- Marketing start
- 2024-07-15
- Substance
- ZOLMITRIPTAN
- Active strength
- 2.5 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZOMIG
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLMITRIPTAN | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2FS66TH3YW |
| Rxcui | 402000, 402169, 1483677, 1483679 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64896-083-12 | ZOMIG | 6 in 1 CARTON | SPRAY, METERED | 6 | | 6 |
| 64896-083-12 | ZOMIG | 1 in 1 BOTTLE, SPRAY | SPRAY, METERED | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64896-083 | ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [AMNEAL PHARMACEUTICALS LLC] | 4 | Current NDC, 2 package rows | 20240828_2438c223-605b-4885-afc3-a6794f190f89.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 64896-083-12 | 64896008312 | 6 BOTTLE, SPRAY in 1 CARTON (64896-083-12) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY | 2024-07-15 | No | No | Current |